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

NCT04267562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2024-11-18

Study results available
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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.

Conditions

  • Menorrhagia
  • Heavy Menstrual Bleeding
  • Heavy Uterine Bleeding

Interventions

DEVICE

Minitouch System

The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System

Sponsors & Collaborators

  • MicroCube, LLC

    lead INDUSTRY

Principal Investigators

  • Scott G Chudnoff, MD, MSc · Maimonides Medical Center

  • Amy Brenner, MD · Amy Brenner, MD & Associates, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2022-07-20
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04267562 on ClinicalTrials.gov