Uterine Fibroids, Uterine Myomas
Conditions
Keywords
Uterine Fibroids, Myomas
Brief summary
The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibroids.
Detailed description
In this single-arm study, subjects who have symptomatic uterine fibroids will have laparoscopic surgery in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.
Interventions
DEVICEHalt Procedure
The Halt 2000 Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative, coagulation and ablation of soft tissue.
Sponsors
Acessa Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Are premenopausal and ≥ 25 years old * Have symptomatic uterine fibroids * Have a uterine gestational size ≤14 weeks as determined by pelvic exam * Have ≤ 6 (six) treatable fibroids in whom no single fibroid exceeds 7 cm in any diameter as measured by ultrasound or magnetic resonance imaging (MRI). Only Fibroids greater than 1cm in diameter should be treated in this study * Have a total uterine fibroid volume that does not exceed 300cc on ultrasound or contrast-enhanced MRI evaluation * Have clinical menorrhagia as indicated by menstrual blood loss of ≥160 mL to 500 ml during one baseline cycle or two baseline cycles within three months prior to treatment * Have a history of at least 3 months of menorrhagia within the last six months * Desire uterine preservation * Do not desire current or future childbearing * Have a normal coagulation profile international normalized ratio (INR), Platelets, Prothrombin Time, and Partial Thromboplastin Time (PTT) * Have had a normal Pap smear within the past 12 months * Are practicing non-hormonal or stable hormonal contraception * If the woman is not currently taking any hormonal contraceptives, has been off all hormonal contraceptives for a minimum of three months prior to study enrollment, and agrees to continue without change in regimen through the 12 months of follow-up OR * If the woman is currently taking hormonal contraceptives, has taken hormonal contraceptives for a minimum of three months prior to study enrollment, and agrees to continue without change in regimen through 12 months of follow up.\*\* \*\*Note: Hormonal contraceptive use must be terminated 30 days prior to treatment but should be resumed post-operatively within 60 days post treatment as instructed by the Investigator. * Are willing and able to comply with all study tests, procedures, and assessment tools * Are willing and able to return for all required follow up visits following study enrollment * Must pass a pre-operative health exam (ASA I-III) * Are capable of providing informed consent
Exclusion criteria
* Have contraindications for laparoscopic surgery and/or general anesthesia. (Contraindications include anemia, defined as a hemoglobin level under 10 or hematocrit level less than 30.) * Have had prior pelvic surgery (with the exception of C-section, tubal ligation, or diagnostic laparoscopy), or are known to have significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus) * Have previously undergone endometrial ablation, uterine artery embolization, or uterine artery ligation, or any other uterine-preserving technique for reduction of menstrual bleeding (with the exception of hysteroscopic myomectomy \> 1 year ago) * Patients requiring elective concomitant procedures * Have contraindications for magnetic resonance imaging (MRI) * Desire current or future childbearing * Are pregnant or lactating * Have taken any Gonadotropin-releasing hormone (GnRh) agonist within three months prior to the screening procedures * Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed one month prior to treatment * Have dysfunctional uterine bleeding or bleeding between periods * Have chronic pelvic pain not due to uterine fibroids * Have known or suspected endometriosis * Have known or suspected adenomyosis based on Ultrasound or MRI findings * Have active or history of pelvic inflammatory disease * Have a history of or evidence of gynecologic malignancy or pre-malignancy within the past five years * Have had pelvic radiation * Have a non-uterine pelvic mass * Have a cervical myoma * Have one or more pedunculated subserosal fibroids or type zero (completely intracavitary) submucous fibroids * Are peri-menopausal (defined as women 40 years of age or older with Follicular Stimulating Hormone level of ≥ 25 International Units (IU) or menopausal * Are unable to give informed consent * In the medical judgment of the investigator should not participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure | 12 months from Baseline | Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate. |
| Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure | 12 months | An adverse event was defined as any untoward medical occurrence in a subject who uses a medical device, regardless of the presumed relationship of the event to the study device. A serious adverse event is defined as an untoward medical occurrence that results in death, is life threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Preexisting conditions (i.e., underlying diseases that were present before the adverse event reporting period began), re-intervention for failure to meet the study endpoints, and pregnancy were not reported as adverse events. All adverse events that occured during the study were recorded on the Adverse Event case report form (CRF). The investigator recorded the adverse event and assessed the relationship of the adverse event to the device and/or procedure; the coding of the events was reviewed by the Clinical Events Committee (CEC). |
| Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment | 12 months from Baseline | Patients who had surgical reintervention for bleeding prior to 12 months follow-up. Surgical reintervention success was defined as no surgical reintervention for menorrhagia within the 12-month posttreatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging) | 12 month from Baseline | Evaluate change from baseline in uterine volume and fibroid volume at 12 months post-procedure as measured by contrast-enhanced magnetic resonance imaging (MRI) measurements. Specifically, the outcomes of uterine and fibroid volume changes are expressed as a mean percentage of volume reduction. Treatment with RFA resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment and posttreatment MRI, at 3 and 12 months posttreatment. |
| Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE) | 12 months | The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment. |
| Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool. | 12 months from Baseline | The Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool measures symptom severity and Health related quality of life. Symptom Severity (SS) - high scores indicate greater symptoms (bad) and low scores indicate less symptoms (good). Scores range from 0 to 100. Since this outcome measure indicates change in symptoms, a negative number indicates a reduction in symptoms and therefore improvement. Health Related (HRQL) - high scores indicate better health state. Scores range from 0 to 100. Since this outcome measure indicates change in health and quality of life, a positive number indicates and improvement. |
| Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome) | 12 months | The EQ-5D is a standardized instrument with scores ranging from 0 to 100, for use as a measure of general health outcome, such as mobility, self-care, usual activities, pain/discomfort and anxiety and depression. An increase in the score post treatment indicates less disease burden. |
Countries
Guatemala, Mexico, United States
Participant flow
Recruitment details
Recruitment began in February 2009 with enrollment of the last patient in February 2011. All subjects were enrolled at nine clinical sites throughout the United States and two clinical sites in Latin America.
Pre-assignment details
Subjects were excluded for the following: radiologic evidence by MRI of adenomyosis (n = 127), pedunculated subserosal or intracavitary myomas (n = 43), a history of pelvic malignancy, cervical dysplasia, a prior procedure to treat or remove myomas (n = 22), and contraindications to anesthesia or abdominal surgery (n = 12).
Participants by arm
| Arm | Count |
|---|---|
| Halt Medical Acessa Procedure In this single-arm study, subjects who have symptomatic uterine fibroids had the Acessa Procedure using the Halt Medical Proprietary Acessa System. The Acessa System delivers monopolar radiofrequency energy to tissue through a disposable electrosurgical radiofrequency (RF) Handpiece. The Generator provides sinusoidally-varying voltage at 460 kilohertz (kHz) to drive a current through the tissue to be ablated. The current delivered through the Handpiece causes controlled, local heating, resulting in targeted tissue destruction. The heat produced then disperses by conduction. During these controlled ablations, the Generator produces an alternating current which flows between the Handpiece and the dispersive electrode pads, through the body of the patient. These components, coupled with the visualization capabilities of laparoscopic ultrasound, enable the surgeon to accurately identify the patient's uterine fibroids and treat all of her fibroids, and just the fibroids. | 137 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 4 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Halt Medical Acessa Procedure |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 137 Participants |
| Age, Continuous Age Latin America (n=51) | 40.7 years FULL_RANGE 4.9 |
| Age, Continuous Age US Sites (n=86) | 43.4 years FULL_RANGE 4 |
| Region of Enrollment Guatemala | 23 participants |
| Region of Enrollment Mexico | 28 participants |
| Region of Enrollment United States | 86 participants |
| Sex: Female, Male Female | 137 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 137 |
| serious Total, serious adverse events | 15 / 137 |
Outcome results
Primary
Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure
Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate.
Time frame: 12 months from Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure | 50% change in MBF | 40.2 Percentage of participants |
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure | 40% change in MBF | 48.8 Percentage of participants |
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure | 30% change in MBF | 59.1 Percentage of participants |
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure | 22% change in MBF | 67.7 Percentage of participants |
Primary
Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure
An adverse event was defined as any untoward medical occurrence in a subject who uses a medical device, regardless of the presumed relationship of the event to the study device. A serious adverse event is defined as an untoward medical occurrence that results in death, is life threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Preexisting conditions (i.e., underlying diseases that were present before the adverse event reporting period began), re-intervention for failure to meet the study endpoints, and pregnancy were not reported as adverse events. All adverse events that occured during the study were recorded on the Adverse Event case report form (CRF). The investigator recorded the adverse event and assessed the relationship of the adverse event to the device and/or procedure; the coding of the events was reviewed by the Clinical Events Committee (CEC).
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure | 5 participants |
| Procedural | Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure | 33 participants |
Primary
Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment
Patients who had surgical reintervention for bleeding prior to 12 months follow-up. Surgical reintervention success was defined as no surgical reintervention for menorrhagia within the 12-month posttreatment period.
Time frame: 12 months from Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment | 0 participants |
Secondary
Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool.
The Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool measures symptom severity and Health related quality of life. Symptom Severity (SS) - high scores indicate greater symptoms (bad) and low scores indicate less symptoms (good). Scores range from 0 to 100. Since this outcome measure indicates change in symptoms, a negative number indicates a reduction in symptoms and therefore improvement. Health Related (HRQL) - high scores indicate better health state. Scores range from 0 to 100. Since this outcome measure indicates change in health and quality of life, a positive number indicates and improvement.
Time frame: 12 months from Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool. | -34.93 Units on a scale | Standard Deviation 23.339 |
| Procedural | Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool. | 42.12 Units on a scale | Standard Deviation 23.06 |
Secondary
Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome)
The EQ-5D is a standardized instrument with scores ranging from 0 to 100, for use as a measure of general health outcome, such as mobility, self-care, usual activities, pain/discomfort and anxiety and depression. An increase in the score post treatment indicates less disease burden.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome) | 15.2 Units on a scale | Standard Deviation 20.219 |
Secondary
Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging)
Evaluate change from baseline in uterine volume and fibroid volume at 12 months post-procedure as measured by contrast-enhanced magnetic resonance imaging (MRI) measurements. Specifically, the outcomes of uterine and fibroid volume changes are expressed as a mean percentage of volume reduction. Treatment with RFA resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment and posttreatment MRI, at 3 and 12 months posttreatment.
Time frame: 12 month from Baseline
Population: The Full Analysis Set (FAS) was used in the analysis of the change in total uterine and fibroid volumes between baseline and 12 months post treatment. Of the 137 Subjects enrolled, two were excluded from the FAS because they did not meet all of the inclusion/exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging) | -25 percentage of volume | 95% Confidence Interval 135.7 |
| Procedural | Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging) | -44.3 percentage of volume | 95% Confidence Interval 47.98 |
Secondary
Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)
The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE) | Somewhat Satisfied/Effective | 12.1 percentage of patients |
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE) | Moderately Satisfied/Effective | 21.0 percentage of patients |
| Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment | Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE) | Very Satisfied/Effective | 61.3 percentage of patients |
| Procedural | Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE) | Somewhat Satisfied/Effective | 14.5 percentage of patients |
| Procedural | Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE) | Moderately Satisfied/Effective | 29.8 percentage of patients |
| Procedural | Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE) | Very Satisfied/Effective | 50.0 percentage of patients |