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

Not Applicable

Completed

Conditions: Menorrhagia
Heavy Menstrual Bleeding
Heavy Uterine Bleeding

Interventions: Device: Minitouch System

Registration Number: NCT04267562

Lead Sponsor: MicroCube, LLC

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 219

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Arm, Open-Label Treatment with the Minitouch System	Minitouch System	Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding	>Month 24 through Month 36 post-procedure	Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.
Number of Trial Participants With Amenorrhea	Month 36 post-procedure	Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)
Dysmenorrhea-related Pain Score	Baseline and Month 36 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 and Month 36 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 and Month 36 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
Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities	Baseline and Month 36 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
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

Trial Locations

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
OBGYN North
🇺🇸
Austin, Texas, United States