Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness

Study Overview
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Brief Summary
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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
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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).

Official Title
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Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (EASE Clinical Trial)

Conditions
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Menorrhagia, Heavy Menstrual Bleeding, Heavy Uterine Bleeding

Intervention / Treatment
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* Device: Minitouch System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Qualified participants must meet all of the following inclusion criteria. Female age 30 to 50 years Excessive menstrual bleeding due to benign causes Uterine sounding depth measurement of 6.0 - 12.0 cm A minimum uterine cavity length of 4.0 cm 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 Endometrial biopsy within 12 months prior to treatment procedure with no abnormal pathology Premenopausal at screening as determined by FSH measurement ≤ 40 IU/L when age is ≥ 40 years 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 Ability to provide written informed consent Patient is literate and clearly demonstrates understanding on how to use PBLAC after training 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 exclusion criteria. Pregnant, or desires to retain fertility Current or documented history of endometrial hyperplasia Active endometritis Clinically significant or suspected adenomyosis indicated by patient complaints, imaging, or clinician's judgment Active infection of the genitals, vagina, cervix, uterus, adnexa, or urinary tract Active pelvic inflammatory disease Currently using an intrauterine device (IUD), including Mirena™ device, and unwilling to remove the IUD Presence of an implantable contraceptive device (e.g., Essure®) protruding into the uterine cavity Active sexually transmitted disease (STD) at the time of ablation Presence of bacteremia, sepsis, or other active systemic infection Currently on anticoagulants Known clotting defects or bleeding disorders Currently on medications that could thin the myometrium, such as long-term steroid use Previous medical/surgical treatments, or has other conditions, that could lead to anatomic/pathologic weakness or thinning of the myometrium Any general health, mental health or social situation which, in the opinion of the investigator, could represent an increased risk for the patient, or the ability of the patient to complete study requirements Known/suspected abnormal uterine/pelvic anatomy or condition, such as frozen pelvis Abdominal, pelvic or gynecological malignancy Untreated/unevaluated cervical dysplasia, except cervical intrepithelial neoplasia I (CIN I) Previous endometrial ablation procedure Abnormal or obstructed, or perforated cavity as determined by investigator via standard clinical practices (e.g., hysteroscopy, saline infusion sonohysterography). Intramural or subserosal myomas > 3 cm in size, or any myoma that distorts the uterine cavity Any patient who is currently participating or considering participation in any other research of an investigational drug or device

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-Arm, Open-Label Treatment with the Minitouch System<br>Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System | Device: Minitouch System<br>* The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Month 12 post-procedure | 
| 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. | Month 12 post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Month 12 post-procedure | 
| Number of Trial Participants With Amenorrhea | Secondary Effectiveness Outcome Measure - Amenorrhea rates where PBLAC = 0 (no bleeding) | Month 6 and Month 12 post-procedure | 
| 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) | Pre-Procedure (on day of, prior to procedure), Discharge (post-procedure, prior to discharge) and 24-hours post-procedure | 
| 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. | Baseline, Month 6 and Month 12 post-procedure | 
| 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 | Baseline, Month 6 and Month 12 post-procedure | 
| 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 | Baseline, Month 6 and Month 12 post-procedure | 
| 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 | Baseline, Month 6 and Month 12 post-procedure | 
| 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 | Day of Procedure (prior to the procedure) | 
| 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 | Day of Procedure (during the procedure) | 
| Procedure Details: Recovery Time | Secondary Outcome Measure - Total Procedure Recovery Time Time frame: assessed on the day of procedure/post-procedure, prior to discharge | Day of Procedure (post-procedure, prior to discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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excessive menstrual bleeding, menorrhagia, heavy menstrual bleeding, heavy uterine bleeding, menstrual disorders, menstruation disturbances