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NCT04267562 · ClinicalTrials.gov registry record · NA
Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness
A NA study of Menorrhagia and Heavy Menstrual Bleeding, sponsored by MicroCube.
- Completed
- Registry status
- NA
- Development phase
- 219
- Enrollment target
- 5
- Study locations
NCT04267562: Completed NA study of Menorrhagia and Heavy Menstrual Bleeding, sponsored by MicroCube.
NCT04267562 is a NA study of Menorrhagia and Heavy Menstrual Bleeding that has completed, run by MicroCube. The registered enrollment target is 219 participants, roughly in line with the 207-participant average among 10 other Menorrhagia trials with a reported enrollment target. The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04267562, a NA study of Menorrhagia and Heavy Menstrual Bleeding, has completed, sponsored by MicroCube.
- COMPLETED
- Registry status
- NA
- Development phase
- 219 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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,
Conditions Studied
Interventions
- DEVICE Minitouch System
Study Locations (5)
Texas
- Women's Health Texas (Women Partners in Health) - Austin
- AA ObGyn - Austin
- OBGYN North - Austin
Indiana
- CMB Research - Newburgh
Ohio
- Amy Brenner, MD & Associates - Mason
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2020-02-28 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
What the finished NCT04267562 record still lists
NCT04267562 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 207-participant average among 10 other Menorrhagia trials with a reported enrollment target.
The record links to 3 conditions, with Menorrhagia appearing as the primary indexed condition, and to 1 intervention - of which Minitouch System is the first listed.
NCT04267562 lists 5 locations in 3 states (Texas, Indiana, Ohio).
Frequently Asked Questions
What is clinical trial NCT04267562 about?
NCT04267562 is a clinical study titled "Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness". 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.
What is the current status of trial NCT04267562?
This trial is currently completed. It is a NA study. The enrollment target is 219 participants. The study started on 2020-02-28. Estimated completion is 2023-12-31.
What conditions does trial NCT04267562 study?
This clinical trial studies the following conditions: Menorrhagia, Heavy Menstrual Bleeding, Heavy Uterine Bleeding.
What interventions are being tested in trial NCT04267562?
The interventions under investigation include: Minitouch System (DEVICE).
Who is sponsoring clinical trial NCT04267562?
This trial is sponsored by MicroCube, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04267562 being conducted?
This trial has 5 study locations across Indiana, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Menorrhagia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04267562's enrollment target sits among peer trials
219 4th of 10 higher than 7 of 10 other Menorrhagia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menorrhagia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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