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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-AEGEA Pivotal Clinical Study


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General
Study Status Study Pending
Application Number P160047 / PAS001
Study Name ODE lead-AEGEA Pivotal Clinical Study
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 Design Description The AEGEA Pivotal Clinical Trial (Protocol SE-3000) is a prospective, single-arm, non-randomized, multicenter, open label clinical trial to evaluate the safety and effectiveness of the AEGEA Vapor System™ for the treatment of excessive menstrual bleeding. Subjects were enrolled at fourteen investigational sites in the United States, Mexico, Canada, and The Netherland.



The AEGEA Pivotal Clinical Trial was divided into two groups: Safety subjects (or Safety cohort) and Pivotal subjects (or Pivotal cohort). Sixty-six (66) Safety subjects and 155 Pivotal subjects were evaluated. The primary analysis population for safety and effectiveness for this study was the Intent-to-Treat (ITT) population for the Pivotal subjects. Safety results from the Safety subjects were considered as part of the evaluation of device safety.



Data from the Pivotal cohort are the basis of effectiveness outcome analyses to support this PMA. Data from the Safety cohort is not included in the effectiveness analysis, but it is considered as a part of safety evaluation.



Follow-up of Pivotal cohort occurred at 24 hours post-procedure, 2 weeks and 3, 6, and 12 months post-procedure prior to PMA submission. The applicant intends to continue follow-up in the post-market setting to collect long-term outcome in Pivotal cohort at two and three years.

Study Population Description The demographics of the study population (Pivotal subjects) are typical for an endometrial ablation study performed in the United States. Seventy-six (76) patients were 30-39 years old, and seventy-nine (79) patients were 40-50 years old. The mean age of subjects at baseline was 39.8. An evaluation of these data confirmed the data could be pooled across sites and countries.



Sample Size One hundred and thirty-seven (137) of 155 Pivotal subjects enrolled in the premarket study are available for postmarket follow-up.



Data Collection 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 Three years


ODE lead-AEGEA Pivotal Clinical Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 06/14/2018    
two year report 06/14/2019    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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