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

MicroCube, LLC219 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

219

Conditions

Menorrhagia Heavy Menstrual Bleeding Heavy Uterine Bleeding

Interventions

Minitouch SystemDEVICE

The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 exclusion criteria. 1. Pregnant, or desires to retain fertility 2. Current or documented history of endometrial hyperplasia 3. Active endometritis 4. Clinically significant or suspected adenomyosis indicated by patient complaints, imaging, or clinician's judgment 5. Active infection of the genitals, vagina, cervix, uterus, adnexa, or urinary tract 6. Active pelvic inflammatory disease 7. Currently using an intrauterine device (IUD), including Mirena™ device, and unwilling to remove the IUD 8. Presence of an implantable contraceptive device (e.g., Essure®) protruding into the uterine cavity 9. Active sexually transmitted disease (STD) at the time of ablation 10. Presence of bacteremia, sepsis, or other active systemic infection 11. Currently on anticoagulants 12. Known clotting defects or bleeding disorders 13. Currently on medications that could thin the myometrium, such as long-term steroid use 14. Previous medical/surgical treatments, or has other conditions, that could lead to anatomic/pathologic weakness or thinning of the myometrium 15. 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 16. Known/suspected abnormal uterine/pelvic anatomy or condition, such as frozen pelvis 17. Abdominal, pelvic or gynecological malignancy 18. Untreated/unevaluated cervical dysplasia, except cervical intrepithelial neoplasia I (CIN I) 19. Previous endometrial ablation procedure 20. Abnormal or obstructed, or perforated cavity as determined by investigator via standard clinical practices (e.g., hysteroscopy, saline infusion sonohysterography). 21. Intramural or subserosal myomas \> 3 cm in size, or any myoma that distorts the uterine cavity 22. Any patient who is currently participating or considering participation in any other research of an investigational drug or device

Locations (5)

CMB Research

Newburgh, Indiana, United States

Amy Brenner, MD & Associates

Mason, Ohio, United States

Women's Health Texas (Women Partners in Health)

Austin, Texas, United States

AA ObGyn

Austin, Texas, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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

Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding

Data from ClinicalTrials.gov

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Austin, Texas, United States

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

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

Number of Trial Participants With Amenorrhea

Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)

Time frame: Month 24 post-procedure

Number of Trial Participants With Amenorrhea

Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)

Time frame: Month 36 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.

Time frame: Baseline, Month 6 and Month 12 post-procedure

Dysmenorrhea-related Pain Score

Time frame: Baseline and Month 24 post-procedure

Dysmenorrhea-related Pain Score

Time frame: Baseline and Month 36 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

Time frame: Baseline, Month 6 and Month 12 post-procedure

Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home

Time frame: Baseline and Month 24 post-procedure

Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home

Time frame: Baseline and Month 36 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

Time frame: Baseline, Month 6 and Month 12 post-procedure

Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity

Time frame: Baseline and Month 24 post-procedure

Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity

Time frame: Baseline and Month 36 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

Time frame: Baseline, Month 6 and Month 12 post-procedure

Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities

Time frame: Baseline and Month 24 post-procedure

Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities

Time frame: Baseline and Month 36 post-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

Time frame: Day of Procedure (during the 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

Time frame: Day of Procedure (prior to the 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)

Time frame: Pre-Procedure (on day of, prior to procedure), Discharge (post-procedure, prior to discharge) and 24-hours post-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

Time frame: Day of Procedure (post-procedure, prior to discharge)