f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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EASE Clinical Trial


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General
Study Status Ongoing
Application Number /
Requirement Number		 P230002 / PAS001
Date Original Protocol Accepted 07/28/2023
Date Current Protocol Accepted  
Study Name EASE Clinical Trial
Device Name Minitouch 3.8 Era System (Minitouch System)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives To evaluate the safety and effectiveness of the Minitouch System for treatment of menorrhagia due to benign causes in premenopausal women for whom childbearing is complete.
Prospective, single-arm, non-randomized, multi-center clinical trial
Sample Size 114
Key Study Endpoints At least 85% of the current patient cohort must be followed out to 36 months post procedure. The following outcomes will be provided:
Need for surgical or medical intervention to treat abnormal bleeding
Subject self-report of pregnancy
Contraception status (data to be collected at 3 years only)
Menstrual status
Gynecologic adverse events
Quality of Life Questionnaire
Patient Satisfaction
Follow-up Visits and Length of Follow-up 36 months


EASE Clinical Trial Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 01/26/2024 01/26/2024 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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