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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020014 / PAS001 |
| Date Original Protocol Accepted |
11/04/2002
|
| Date Current Protocol Accepted |
11/04/2002
|
| Study Name |
Newly Trained Physicians
|
| Device Name |
ESSURE SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Cross-Sectional Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study was designed to document the bilateral placement rate at first attempt for newly trained physicians in the U.S. These data were used to evaluate the training procedures and to update labeling.
|
| Study Population |
Study population as per device indication . This device is indicated for permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes in adult women seeking permanent birth control.
|
| Sample Size |
The study was originally designed to enroll 800 women from 40 physicians in the commercial setting.
|
| Key Study Endpoints |
Data collected included: (1) successful bilateral placement rate at first attempt, and (2) identification of factors predictive of failure to achieve bilateral placement at first attempt.
|
| Follow-up Visits and Length of Follow-up |
No patient follow-up was conducted as part of this study, with the exception of the follow-up data of the HSGs performed to evaluate the reasons for placement failure in women who desired a second attempt of device placement.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
After reviewing the final report, the Agency considered the conditions of approval for this study to be satisfied, with 514 women enrolled.
|
| Actual Number of Sites Enrolled |
39
|
| Patient Follow-up Rate |
N/A
|
| Final Safety Findings |
Safety: There were 38 malfunctions in 27 cases, in 9 the distal tip was bent, the sponsor does not consider these are malfunctions. There were no reports of adverse events related to bent tips. There were 29 device malfunctions that included detachment problems, deployment issues, thumbwheel retraction difficulty, inner sleeve detachment and failure of delivery catheter to retract.
Placement rate: There were 13 adverse events that included perforation, pelvic pain, bleeding, light headed, increased blood pressure and temporary decreased pulse.
There were 476 women in whom bilateral placement was possible. After excluding all confounding, bilateral placement was achieved in 458 women for 96.2% (458/476) success rate. Bilateral failure happened in 10 women for 2.1% failure rate (10/476). After original approval of Essure system a new coil catheter was approved. The sponsor did a comparison of success rate by design. After excluding all confounding there were 184 procedures with the original model (gamma) and 297 procedures with the new model (coil catheter design). The new model performed better than the old, with a 96.0% success rate for the new coil catheter and 94.0% for the gamma model. Additionally, bilateral failure was less frequent with the new model (1.3% vs. 3.3%). The gamma model was discontinued in September 2003.
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| Study Strengths & Weaknesses |
Study provided precise estimate of bilateral placement at first attempt among newly trained physicians. Although the sponsor did not enroll the required number of women as per protocol, they were able to demonstrate with Bayesian statistics, that the observed rate was not diffderent from the rate observed in experienced physcians.
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| Recommendations for Labeling Changes |
Update label to include results from the PAS(bilaeral placement rate from newly trained physicians). Labeling should include the information on the number of patients excluded and why these patients were excluded from the post-approval study.
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