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.
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).
Eligibility
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