NCT04267562

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

Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (EASE Clinical Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: MicroCube, LLC · Industry
• Sex: Female
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Menorrhagia
• Heavy Menstrual Bleeding
• Heavy Uterine Bleeding

Interventions

Type	Name	Description
DEVICE	Minitouch System	The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System

Timeline

• Start date: 2020-02-28
• Primary completion: 2022-07-20
• Completion: 2023-12-31
• First posted: 2020-02-13
• Last updated: 2024-11-18
• Results posted: 2023-10-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study