|
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
|