|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P040050 / PAS002 |
Date Original Protocol Accepted |
10/30/2006
|
Date Current Protocol Accepted |
10/30/2006
|
Study Name |
Enhanced Surveillance
|
Device Name |
MACROPLASTIQUE IMPLANTS
|
General Study Protocol Parameters |
Study Design |
Enhanced Surveillance
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
Enhanced surveillance to rapidly assess potential adverse events related to the use of Macroplastique following its launch in the U.S. marketplace. It involved the active solicitation of information on adverse events associated with Macroplastique from all U.S. physician customers on a quarterly basis for two years following PMA approval.
|
Study Population |
All patients receiving the device. The device is indicated for women who have stress urinary incontinence due to poorly functioning urethral sphincter muscles.
|
Sample Size |
N/A
|
Key Study Endpoints |
Information on patient characteristics, treatment and retreatment, and onset, severity, and resolution of the event are to be obtained only if the customers have reportable events.
|
Follow-up Visits and Length of Follow-up |
N/A
|
Interim or Final Data Summary |
Interim Results |
Study completed, see final results
|
Actual Number of Patients Enrolled |
N/A
|
Actual Number of Sites Enrolled |
N/A
|
Patient Follow-up Rate |
87%
|
Final Safety Findings |
No serious adverse events were identified by the Enhanced Surveillance Program since device was launched to market in the U.S through March 2008. The data for enhanced surveillance was collected for 2 years as per approval order.
|
Study Strengths & Weaknesses |
Enhanced surveillance system with high response rate from participating physicians.
|
Recommendations for Labeling Changes |
Update labeling to reflect the results of the Post-Approval Study
|