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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Genesys HTA Post Approval Registry


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General
Study Status Completed
Application Number /
Requirement Number		 P000040 S014/ PAS001
Date Original Protocol Accepted 04/23/2012
Date Current Protocol Accepted 04/23/2012
Study Name Genesys HTA Post Approval Registry
Device Name GENESYS HTA SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives A Multi-center, Single-arm, Prospective Registry of the Genesys HTATM System for the Treatment of Menorrhagia will evaluate safety and technical performance of the device at time of treatment.
Study Population All women treated with the Genesys HTATM System under the approved indications for use who agree to participate
Sample Size 1312 subjects at a maximum of 100 clinical sites
Key Study Endpoints Rate of clinically significant burns (primary)
Rate of technical complaints with the system (secondary)
Assessment of serious adverse events (secondary)
Interim or Final Data Summary
Actual Number of Patients Enrolled 1,014
Actual Number of Sites Enrolled 18
Patient Follow-up Rate 91.8% (931/1,014)
Final Safety Findings There have been 4 burn events: 3 non-clinically significant burns and 1 clinically significant burn were reported. The rate of this clinically significant event was 0.1% (95% CI 0.0%, 0.6%). The primary hypothesis of the PAS is that the subject rate of clinically significant burns is not significantly greater than 1.0%.

For the secondary endpoint, there has been one (1) Serious Adverse Device Effect. This was a superficial 2nd degree burn for a subject for a rate of 0.1% (95% CI: 0.0% ¿ 0.6%).
Final Effect Findings There was no effectiveness endpoint per se. The secondary objective of the study was to obtain data on technical problems with the device. Fifty-three (53) technical complaints were reported for 44 subjects in the intent-to-treat population (N=992). Therefore, the rate of technical complaints per subject was 5.3% (53/992).
Study Strengths & Weaknesses This study had an adequate sample size that was large enough to study key safety issues.
Recommendations for Labeling Changes No labeling changes are recommended


Genesys HTA Post Approval Registry Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/22/2010 10/22/2010 On Time
one year report 04/23/2011 04/22/2011 On Time
18 month report 10/22/2011 10/24/2011 Overdue/Received
two year report 04/22/2012 04/18/2012 On Time
Final PAS Report 10/22/2012 10/19/2012 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

Additional Resources

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