Abnormal Uterine Bleeding, Infertility
Conditions
Keywords
morcellator, hysteroscope, myomectomy, polypectomy, uterine fibroids
Brief summary
This study assesses the effectiveness of intrauterine fibroid and polyp removal using the Interlace Medical 1st generation hysteroscopic morcellator device based on a retrospective review of medical records of women who have been treated with the device.
Detailed description
A retrospective review of medical records for eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator was conducted at four hospital or ambulatory surgical center sites. Four physicians performed hysteroscopic operative procedures to remove intrauterine polyps, type 0 (completely within the uterine cavity), type I (mostly within the cavity) and type II (\< 40% within the cavity) submucous myomas. Percent pathology removed, total morcellation time, total fluid used, fluid deficit and treatment-related adverse events were assessed. Each of the four treating physicians also evaluated device performance using a 10 point scale (1 = poor and 10 = excellent).
Interventions
DEVICEInterlace Medical 1st Generation Hysteroscopic Morcellator
The Interlace Medical hysteroscopic morcellator system has been cleared by the FDA(K073690)and consists of a motor drive unit connected to a 3mm morcellator. The morcellator is approximately 12 cm long and is equipped with an open channel that houses a reciprocating blade. When the motor is activated, the reciprocating blade will cut the tissue within the channel. The tissue travels down the 3mm morcellator shaft cannula via suction coupled to the proximal end of the morcellator and is captured in a tissue trap in a suction canister for pathological diagnosis following the procedure.
Sponsors
Hologic, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* female * at least 18 years old * treated for intra-uterine submucosal fibroids (Type 0 or 1 myomas and/or polyps using the Interlace 1st generation morcellator device.
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Tissue Removed | immediately post-treatment | mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluid Volume Per Procedure | at time of treatment | mean volume of distension fluid infused into the uterus, per procedure. Distention fluid is used to distend the uterus and provide increased visibility. |
| Fluid Deficit Per Procedure | at time of treatment | mean fluid deficit per procedure. Fluid deficit is the difference between the amount of fluid which is infused into the patient during the hysteroscopic procedure, and the amount of fluid collected at completion of the procedure. |
| Treatment Time Per Patient | at time of treatment | mean morcellation(division into and removal of small pieces, as of tissue) time per patient |
| Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score | 2-3 months post treatment | a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator(1 = poor and 10 = excellent). |
| Adverse Events | 2-3 months post-treatment | Patient medical records were examined to identify any procedure-related or post-treatment adverse events. An adverse event is any undesirable experience (sign, symptom, illness, or other medical event) occurring in a subject, that appears or worsens during a clinical study |
| Resected Tissue Weight Per Patient | at time of treatment | mean weight of resected tissue per patient |
Participant flow
Recruitment details
An unselected series of eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator at four hospital or ambulatory surgical center sites were assessed for this study.
Participants by arm
| Arm | Count |
|---|---|
| Hysteroscopic Morcellator Treatment Group Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Hysteroscopic Morcellator Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age Continuous | 40.5 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
| size of fibroid or polyp | 16.3 mm |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Percentage of Tissue Removed
mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite.
Time frame: immediately post-treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hysteroscopic Morcellator Treatment Group | Percentage of Tissue Removed | 97.5 Percentage of tissue removed |
Secondary
Adverse Events
Patient medical records were examined to identify any procedure-related or post-treatment adverse events. An adverse event is any undesirable experience (sign, symptom, illness, or other medical event) occurring in a subject, that appears or worsens during a clinical study
Time frame: 2-3 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hysteroscopic Morcellator Treatment Group | Adverse Events | 0 events |
Secondary
Fluid Deficit Per Procedure
mean fluid deficit per procedure. Fluid deficit is the difference between the amount of fluid which is infused into the patient during the hysteroscopic procedure, and the amount of fluid collected at completion of the procedure.
Time frame: at time of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hysteroscopic Morcellator Treatment Group | Fluid Deficit Per Procedure | 567.8 mL |
Secondary
Fluid Volume Per Procedure
mean volume of distension fluid infused into the uterus, per procedure. Distention fluid is used to distend the uterus and provide increased visibility.
Time frame: at time of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hysteroscopic Morcellator Treatment Group | Fluid Volume Per Procedure | 5179.0 mL |
Secondary
Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score
a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator(1 = poor and 10 = excellent).
Time frame: 2-3 months post treatment
Population: All treating physicians completed a survey questionnaire.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hysteroscopic Morcellator Treatment Group | Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score | 9.5 scores on a scale |
Secondary
Resected Tissue Weight Per Patient
mean weight of resected tissue per patient
Time frame: at time of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hysteroscopic Morcellator Treatment Group | Resected Tissue Weight Per Patient | 10.8 g |
Secondary
Treatment Time Per Patient
mean morcellation(division into and removal of small pieces, as of tissue) time per patient
Time frame: at time of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hysteroscopic Morcellator Treatment Group | Treatment Time Per Patient | 4.3 minutes |