Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effect… (NCT04267562) | Clinical Trial Compass
CompletedNot Applicable
Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness
United States219 participantsStarted 2020-02-28
Plain-language 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.
Who can participate
Age range
30 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75)
Timeframe: Month 12 post-procedure
2
Number of Trial Participants With Device or Procedure-related Serious Adverse Events
. 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
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