In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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 Description
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
Data Collection
Rate of clinically significant burns (primary)
Rate of technical complaints with the system (secondary)
Assessment of serious
adverse events (secondary)
Final Study Results
Actual Number of Patients Enrolled
1,014
Actual Number of Sites Enrolled
18
Patient Followup 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 Effectiveness 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 and Weaknesses
This study had an adequate sample size that was large enough to study key safety issues.
