Heavy Menstrual Bleeding, Heavy Uterine Bleeding, Menorrhagia
Conditions
Keywords
excessive menstrual bleeding, menorrhagia, heavy menstrual bleeding, heavy uterine bleeding, menstrual disorders, menstruation disturbances
Brief summary
The EASE Clinical Trial is prospective, multi-center, single-arm (open-label), non-randomized, clinical trial to evaluate the Minitouch Endometrial Ablation System (Minitouch System) in premenopausal women with menorrhagia.
Detailed description
The EASE Clinical Trial a prospective, multi-center, single-arm (open-label), non-randomized, clinical trial of the safety and effectiveness of endometrial ablation with the Minitouch System versus the FDA identified objective performance criteria (OPC) for global endometrial ablation (GEA) devices. The goal of the trial is to support reasonable safety and effectiveness of the investigational product compared to currently FDA-approved GEA devices. Only eligible participants will undergo the Minitouch procedure. Post-treatment follow-up occurs approximately 24-hours post-procedure (via phone call) and in-person office visits occur 2-weeks, 3, 6 and 12-months post-procedure. Additional longer term follow-ups occur (via phone call or in-person office visits) 24 and 36-months post-procedure. The expected length of participation is approximately 37 months (inclusive of one month for screening and 36-months of post-procedure follow-up).
Interventions
DEVICEMinitouch System
The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
Sponsors
MicroCube, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: Qualified participants must meet all of the following inclusion criteria. 1. Female age 30 to 50 years 2. Excessive menstrual bleeding due to benign causes 3. Uterine sounding depth measurement of 6.0 - 12.0 cm 4. A minimum uterine cavity length of 4.0 cm 5. A minimum PBLAC score of ≥ 150 for 1 menstrual cycle (obtained during screening) and must also have a documented history of excessive menstrual bleeding prior to study enrollment 6. Endometrial biopsy within 12 months prior to treatment procedure with no abnormal pathology 7. Premenopausal at screening as determined by FSH measurement ≤ 40 IU/L when age is ≥ 40 years 8. Patient agrees to use a reliable form of contraception during the study and to follow these requirements: (a) If a hormonal birth control method is used for contraception, the patient must have been on said method for ≥ 3 months prior to the onset of the screening menstrual cycle and agrees to remain on the same hormonal regimen through the initial 12-month post-treatment follow-up (pills, injections, patches, rings, implants); (b) Patient also agrees to not use hormonal birth control during the first 12-month post-treatment follow-up period if they were not using hormonal birth control during the 3 months prior to treatment 9. Ability to provide written informed consent 10. Patient is literate and clearly demonstrates understanding on how to use PBLAC after training 11. Patient agrees to the following during the study: (a) No initiation of hormonal contraception or any other medical intervention for bleeding; (b) Attend all follow-up exams through the 36-month follow-up timepoint; and (c) Exclusive use of study-provided sanitary products and submission of completed PBLAC diaries through the 12-month post-treatment follow-up Key
Exclusion criteria
Qualified participants must NOT meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Trial Participants With Device or Procedure-related Serious Adverse Events | Month 12 post-procedure | The primary safety endpoint is the incidence of device or procedure-related serious adverse events. |
| Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75) | Month 12 post-procedure | The primary effectiveness endpoint is a clinical change in menstrual blood loss as assessed by the Pictorial Blood Loss Assessment Chart (PBLAC) data, a validated, patient self-reported menstrual diary scoring system. Success for the primary effectiveness endpoint was defined as reduction in menstrual bleeding to a PBLAC (Pictorial Blood Loss Assessment Chart) score of ≤75. Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e., no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e., normal menstrual bleeding. A lower PBLAC score indicates less bleeding and a higher PBLAC score indicates more bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Trial Participants With Amenorrhea | Month 6 and Month 12 post-procedure | Secondary Effectiveness Outcome Measure - Amenorrhea rates where PBLAC = 0 (no bleeding) |
| Dysmenorrhea-related Pain Score | Baseline, Month 6 and Month 12 post-procedure | Change in quality of life as measured by Dysmenorrhea-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome. |
| Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline, Month 6 and Month 12 post-procedure | Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 2): Subjects were asked if they had any limitations in work outside or inside the home based on the following categories: not at all, slightly, moderately, quite a bit, extremely |
| Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline, Month 6 and Month 12 post-procedure | Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 3): Subjects were asked if they had any limitations in physical activity based on the following categories: not at all, slightly, moderately, quite a bit, extremelylimitations in social and leisure activities: not at all, slightly, moderately, quite a bit, extremely |
| Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding | Month 12 post-procedure | Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding. |
| Procedure Details: Type of Setting in Which the Procedure Took Place | Day of Procedure (prior to the procedure) | Secondary Outcome Measure - Setting in which the Minitouch Procedure took place Time frame: the type of setting is assessed on day of procedure, prior to the procedure |
| Procedure-related Pain Score | Pre-Procedure (on day of, prior to procedure), Discharge (post-procedure, prior to discharge) and 24-hours post-procedure | Procedure-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome. Timepoints: Pre-procedure (on the day of, prior to the procedure) Discharge (post-procedure, prior to discharge) 24-hours post-procedure (18-48 hours post-procedure) |
| Procedure Details: Recovery Time | Day of Procedure (post-procedure, prior to discharge) | Secondary Outcome Measure - Total Procedure Recovery Time Time frame: assessed on the day of procedure/post-procedure, prior to discharge |
| Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline, Month 6 and Month 12 post-procedure | Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 4): Subjects were asked if they had any limitations in social or leisure activities based on the following categories: not at all, slightly, moderately, quite a bit, extremely |
| Procedure Details: Number of Trial Participants in Which a Cervical Dilator Was Used | Day of Procedure (during the procedure) | Secondary Outcome Measure - Use of Cervical Dilator (Yes / No) Time frame: the need for using a cervical dilator is assessed on day of procedure, during the procedure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Additonal Measure - Contraception Status at Month 36 | Month 36 post-procedure | Count of subject contraception menthods reported at Month 36 to satisfy the post-approval study (PAS) reporting requirements; subjects could report more than one method of contraception so numbers may be greater than the total of subjects |
| Additonal Measure - Subject Self-Report of Pregnancy | Month 36 post-procedure | Count of subject self-report of pregnancy at Month 36 to satisfy the post-approval study (PAS) reporting requirements |
| Additonal Measure - Gynecologic Adverse Events | Month 24 and Month 36 post-procedure | Count of number of subjects that reported gynecologic adverse events through Month 24 and Month 36; |
Countries
United States
Participant flow
Pre-assignment details
A total of 219 subjects were screened for the Trial, and 114 subjects were considered treated-enrolled. The remaining 105 subjects were excluded prior to treatment assignment for the following reasons: 1. Trial enrollment reached: 21.9% (23/105) 2. Withdrawn consent: 8.6% (9/105) 3. Site closure: 5.7% (6/105) 4. Lost to follow-up: 1.9% (2/105) 5. Physician decision: 1.0% (1/105) 6. Screen failure (met one or more exclusion criterion(ia)): 61.0% (64/105)
Participants by arm
| Arm | Count |
|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Minitouch System: The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System | 114 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Assessed for Eligibility | Lost to Follow-up | 2 |
| Assessed for Eligibility | Physician Decision | 1 |
| Assessed for Eligibility | Screen Failure | 64 |
| Assessed for Eligibility | Site closure | 6 |
| Assessed for Eligibility | Trial enrollment reached | 23 |
| Assessed for Eligibility | Withdrawal by Subject | 9 |
| Month 24 | Elective hysterectomy | 1 |
| Month 24 | Lost to Follow-up | 1 |
| Month 36 | Elective hysterectomy | 2 |
| Month 36 | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Single-Arm, Open-Label Treatment With the Minitouch System |
|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 4.66 |
| Baseline PBLAC (Pictorial Blood Loss Assessment Chart) Score | 264.9 score STANDARD_DEVIATION 161.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 108 Participants |
| Region of Enrollment United States | 114 Participants |
| Sex/Gender, Customized Premenopausal females | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 114 |
| other Total, other adverse events | 109 / 114 |
| serious Total, serious adverse events | 3 / 114 |
Outcome results
Primary
Number of Trial Participants With Device or Procedure-related Serious Adverse Events
The primary safety endpoint is the incidence of device or procedure-related serious adverse events.
Time frame: Month 12 post-procedure
Population: The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Number of Trial Participants With Device or Procedure-related Serious Adverse Events | 0 Participants |
Primary
Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75)
The primary effectiveness endpoint is a clinical change in menstrual blood loss as assessed by the Pictorial Blood Loss Assessment Chart (PBLAC) data, a validated, patient self-reported menstrual diary scoring system. Success for the primary effectiveness endpoint was defined as reduction in menstrual bleeding to a PBLAC (Pictorial Blood Loss Assessment Chart) score of ≤75. Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e., no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e., normal menstrual bleeding. A lower PBLAC score indicates less bleeding and a higher PBLAC score indicates more bleeding.
Time frame: Month 12 post-procedure
Population: The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75) | 102 Participants |
Secondary
Dysmenorrhea-related Pain Score
Change in quality of life as measured by Dysmenorrhea-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome.
Time frame: Baseline, Month 6 and Month 12 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Dysmenorrhea-related Pain Score | Baseline | 6.1 score on a scale | Standard Deviation 2.6 |
| Single-Arm, Open-Label Treatment With the Minitouch System | Dysmenorrhea-related Pain Score | Month 6 | 0.9 score on a scale | Standard Deviation 1.5 |
| Single-Arm, Open-Label Treatment With the Minitouch System | Dysmenorrhea-related Pain Score | Month 12 | 0.8 score on a scale | Standard Deviation 1.5 |
Secondary
Dysmenorrhea-related Pain Score
Change in quality of life as measured by Dysmenorrhea-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome.
Time frame: Baseline and Month 36 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Dysmenorrhea-related Pain Score | Baseline | 6.2 score on a scale | Standard Deviation 2.6 |
| Single-Arm, Open-Label Treatment With the Minitouch System | Dysmenorrhea-related Pain Score | Month 36 | 0.9 score on a scale | Standard Deviation 1.7 |
Secondary
Dysmenorrhea-related Pain Score
Change in quality of life as measured by Dysmenorrhea-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome.
Time frame: Baseline and Month 24 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Dysmenorrhea-related Pain Score | Baseline | 6.2 score on a scale | Standard Deviation 2.6 |
| Single-Arm, Open-Label Treatment With the Minitouch System | Dysmenorrhea-related Pain Score | Month 24 | 1.0 score on a scale | Standard Deviation 1.8 |
Secondary
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 2): Subjects were asked if they had any limitations in work outside or inside the home based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Time frame: Baseline and Month 36 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Not at all | 8 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Slightly | 15 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Moderately | 32 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Quite a bit | 32 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Extremely | 20 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 36 | Not at all | 100 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 36 | Slightly | 5 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 36 | Moderately | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 36 | Quite a bit | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 36 | Extremely | 0 Participants |
Secondary
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 2): Subjects were asked if they had any limitations in work outside or inside the home based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Time frame: Baseline, Month 6 and Month 12 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Not at all | 9 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Slightly | 17 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Moderately | 34 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Quite a bit | 34 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Extremely | 20 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 6 | Not at all | 105 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 6 | Slightly | 7 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 6 | Moderately | 2 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 6 | Quite a bit | 0 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 6 | Extremely | 0 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 12 | Not at all | 108 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 12 | Slightly | 3 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 12 | Moderately | 3 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 12 | Quite a bit | 0 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 12 | Extremely | 0 Participants |
Secondary
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 2): Subjects were asked if they had any limitations in work outside or inside the home based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Time frame: Baseline and Month 24 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 24 | Quite a bit | 3 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Not at all | 9 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Slightly | 17 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Moderately | 33 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Quite a bit | 33 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Baseline | Extremely | 20 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 24 | Not at all | 101 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 24 | Slightly | 7 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 24 | Moderately | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home | Month 24 | Extremely | 0 Participants |
Secondary
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 3): Subjects were asked if they had any limitations in physical activity based on the following categories: not at all, slightly, moderately, quite a bit, extremelylimitations in social and leisure activities: not at all, slightly, moderately, quite a bit, extremely
Time frame: Baseline and Month 36 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Not at all | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Slightly | 19 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Moderately | 25 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Quite a bit | 37 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Extremely | 25 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 36 | Not at all | 100 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 36 | Slightly | 4 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 36 | Moderately | 2 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 36 | Quite a bit | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 36 | Extremely | 0 Participants |
Secondary
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 3): Subjects were asked if they had any limitations in physical activity based on the following categories: not at all, slightly, moderately, quite a bit, extremelylimitations in social and leisure activities: not at all, slightly, moderately, quite a bit, extremely
Time frame: Baseline and Month 24 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Not at all | 2 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Slightly | 20 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Moderately | 27 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Quite a bit | 38 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Extremely | 25 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 24 | Not at all | 98 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 24 | Slightly | 10 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 24 | Moderately | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 24 | Quite a bit | 3 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 24 | Extremely | 0 Participants |
Secondary
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 3): Subjects were asked if they had any limitations in physical activity based on the following categories: not at all, slightly, moderately, quite a bit, extremelylimitations in social and leisure activities: not at all, slightly, moderately, quite a bit, extremely
Time frame: Baseline, Month 6 and Month 12 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Not at all | 2 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Slightly | 20 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Moderately | 27 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Quite a bit | 40 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Baseline | Extremely | 25 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 6 | Not at all | 107 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 6 | Slightly | 6 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 6 | Moderately | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 6 | Quite a bit | 0 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month 6 | Extremely | 0 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month12 | Not at all | 106 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month12 | Slightly | 5 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month12 | Moderately | 2 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month12 | Quite a bit | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity | Month12 | Extremely | 0 Participants |
Secondary
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 4): Subjects were asked if they had any limitations in social or leisure activities based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Time frame: Baseline and Month 24 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Not at all | 7 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Slightly | 20 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Moderately | 28 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Quite a bit | 36 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Extremely | 21 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 24 | Not at all | 101 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 24 | Slightly | 7 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 24 | Moderately | 2 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 24 | Quite a bit | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 24 | Extremely | 1 Participants |
Secondary
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 4): Subjects were asked if they had any limitations in social or leisure activities based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Time frame: Baseline and Month 36 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Not at all | 6 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Slightly | 19 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Moderately | 26 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Quite a bit | 36 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Extremely | 20 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 36 | Not at all | 102 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 36 | Slightly | 3 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 36 | Moderately | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 36 | Quite a bit | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 36 | Extremely | 0 Participants |
Secondary
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 4): Subjects were asked if they had any limitations in social or leisure activities based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Time frame: Baseline, Month 6 and Month 12 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Not at all | 7 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Slightly | 20 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Moderately | 30 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Quite a bit | 36 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Baseline | Extremely | 21 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 6 | Not at all | 107 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 6 | Slightly | 6 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 6 | Moderately | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 6 | Quite a bit | 0 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 6 | Extremely | 0 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 12 | Not at all | 108 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 12 | Slightly | 4 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 12 | Moderately | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 12 | Quite a bit | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities | Month 12 | Extremely | 0 Participants |
Secondary
Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding
Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.
Time frame: Month 12 post-procedure
Population: The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding | 0 Participants |
Secondary
Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding
Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.
Time frame: >Month 12 through Month 24 post-procedure
Population: The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding | 2 Participants |
Secondary
Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding
Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.
Time frame: >Month 24 through Month 36 post-procedure
Population: The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding | 1 Participants |
Secondary
Number of Trial Participants With Amenorrhea
Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)
Time frame: Month 36 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Number of Trial Participants With Amenorrhea | 48 participants |
Secondary
Number of Trial Participants With Amenorrhea
Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)
Time frame: Month 24 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Number of Trial Participants With Amenorrhea | 49 participants |
Secondary
Number of Trial Participants With Amenorrhea
Secondary Effectiveness Outcome Measure - Amenorrhea rates where PBLAC = 0 (no bleeding)
Time frame: Month 6 and Month 12 post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Number of Trial Participants With Amenorrhea | Month 6 | 50 participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Number of Trial Participants With Amenorrhea | Month 12 | 59 participants |
Secondary
Procedure Details: Number of Trial Participants in Which a Cervical Dilator Was Used
Secondary Outcome Measure - Use of Cervical Dilator (Yes / No) Time frame: the need for using a cervical dilator is assessed on day of procedure, during the procedure
Time frame: Day of Procedure (during the procedure)
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Procedure Details: Number of Trial Participants in Which a Cervical Dilator Was Used | Yes - cervical dilator used | 9 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Procedure Details: Number of Trial Participants in Which a Cervical Dilator Was Used | No - cervical dilator not used | 105 Participants |
Secondary
Procedure Details: Recovery Time
Secondary Outcome Measure - Total Procedure Recovery Time Time frame: assessed on the day of procedure/post-procedure, prior to discharge
Time frame: Day of Procedure (post-procedure, prior to discharge)
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Procedure Details: Recovery Time | 20.8 minutes | Standard Deviation 22.7 |
Secondary
Procedure Details: Type of Setting in Which the Procedure Took Place
Secondary Outcome Measure - Setting in which the Minitouch Procedure took place Time frame: the type of setting is assessed on day of procedure, prior to the procedure
Time frame: Day of Procedure (prior to the procedure)
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Procedure Details: Type of Setting in Which the Procedure Took Place | Physician's office | 114 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Procedure Details: Type of Setting in Which the Procedure Took Place | Outpatient clinic/facility (surgery center) | 0 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Procedure Details: Type of Setting in Which the Procedure Took Place | Affiliated hospital | 0 Participants |
Secondary
Procedure-related Pain Score
Procedure-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome. Timepoints: Pre-procedure (on the day of, prior to the procedure) Discharge (post-procedure, prior to discharge) 24-hours post-procedure (18-48 hours post-procedure)
Time frame: Pre-Procedure (on day of, prior to procedure), Discharge (post-procedure, prior to discharge) and 24-hours post-procedure
Population: The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Procedure-related Pain Score | Pre-procedure (on the day of, prior to the procedure | 0.6 score on a scale | Standard Deviation 1.5 |
| Single-Arm, Open-Label Treatment With the Minitouch System | Procedure-related Pain Score | Discharge (post-procedure, prior to discharge) | 2.6 score on a scale | Standard Deviation 2.4 |
| Single-Arm, Open-Label Treatment With the Minitouch System | Procedure-related Pain Score | 24-hours post-procedure (18-48 hours post-procedure) | 1.2 score on a scale | Standard Deviation 1.5 |
Other Pre-specified
Additonal Measure - Contraception Status at Month 36
Count of subject contraception menthods reported at Month 36 to satisfy the post-approval study (PAS) reporting requirements; subjects could report more than one method of contraception so numbers may be greater than the total of subjects
Time frame: Month 36 post-procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Contraception Status at Month 36 | Abstinence | 5 participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Contraception Status at Month 36 | Condom | 21 participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Contraception Status at Month 36 | Partner's vasectomy | 48 participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Contraception Status at Month 36 | Tubal sterilization | 30 participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Contraception Status at Month 36 | Hormonal method (includes pills, injections, rings, implants) | 4 participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Contraception Status at Month 36 | Intrauterine devices | 2 participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Contraception Status at Month 36 | Other (includes no method of contraception) | 4 participants |
Other Pre-specified
Additonal Measure - Gynecologic Adverse Events
Count of number of subjects that reported gynecologic adverse events through Month 24 and Month 36;
Time frame: Month 24 and Month 36 post-procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Bacterial vaginosis | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Urinary tract infection | 4 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Bladder pain | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Renal colic | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Renal mass | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Stress urinary incontinence | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Ureterolithiasis | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Urinary incontinence | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Anxiety | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Coital bleeding | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Menopausal symptoms | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Ovarian cyst | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 12 to Month 24: Uterine hemorrage | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 24 to Month 36: Bacterial vaginosis | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 24 to Month 36: Urinary tract infection | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 24 to Month 36: Dysuria | 1 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 24 to Month 36: Dysmenorrhea | 2 Participants |
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Gynecologic Adverse Events | >Month 24 to Month 36: Ovarian cyst | 1 Participants |
Other Pre-specified
Additonal Measure - Subject Self-Report of Pregnancy
Count of subject self-report of pregnancy at Month 36 to satisfy the post-approval study (PAS) reporting requirements
Time frame: Month 36 post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-Arm, Open-Label Treatment With the Minitouch System | Additonal Measure - Subject Self-Report of Pregnancy | 0 Participants |