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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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ODE Lead-Minerva Pivotal Study

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Study Status Progress Adequate
Application Number P140013 / PAS002
Date Current Protocol Accepted 07/25/2015
Study Name ODE Lead-Minerva Pivotal Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Minerva Pivotal Study is a randomized (2:1), controlled, multicenter study to evaluate the safety and effectiveness of the Minerva Endometrial Ablation System. The Post Approval study will collect extended effectiveness and safety data at 2-3 years post treatment.
Study Population Description Pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete or who no longer wish to retain fertility.

The premarket study included a rollerball control group.

Sample Size Up to 162 women (108 treatment arm and 54 control arm)
Data Collection Any treatments or hysterectomy for dysfunctional uterine bleeding

Compliance with contraception

Any pregnancies

Menstrual status (questions assess bleeding, i.e., amenorrhea, spotting hypomenorrhea, eumenorrhea or menorrhagia)

Any gynecological adverse events

Completion of Quality of Life Questionnaire

Follow-up Visits and Length of Follow-up Three years

30 days (data were provided premarket), one year, two year, and three year

ODE Lead-Minerva Pivotal Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 07/26/2016 12/07/2015 On Time
two year report 07/26/2017 07/20/2017 On Time
three year report 07/26/2018   Overdue
four year report 07/26/2019    
five year report 07/25/2020    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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