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 range30 Years – 50 Years
SexFEMALE
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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
Exclusion criteria
✕. Pregnant, or desires to retain fertility
✕. Current or documented history of endometrial hyperplasia
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