|
|
| General |
| Study Status |
Progress Adequate |
Application Number /
Requirement Number |
P020014 S041/ PAS001 |
| Date Original Protocol Accepted |
07/29/2015
|
| Date Current Protocol Accepted |
04/28/2016
|
| Study Name |
Post Approval Study
|
| Device Name |
ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| 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 |
This study is the continuation of the premarket study (Use of Transvaginal Ultrasound to Confirm Essure Micro-insert Placement in Women: Demonstration of Effectiveness) utilized to support P020014/S041.
The study is a prospective, multi-center, international study of women seeking permanent contraception. The objectives of the study are to evaluate the effectiveness of the Essure procedure when the TVU/hysterosalpingogram (HSG) algorithm is used for confirmation testing, evaluate the intent-to-treat reliance rate 3 months following TVU/HSG confirmation test algorithm, and evaluate subject satisfaction with the TVU confirmation test.
|
| Study Population |
Women, aged 21 to 44 years of age, seeking permanent contraception
|
| Sample Size |
620 patients were enrolled.
|
| Key Study Endpoints |
The two co-primary endpoints of the study are to evaluate the occurrence of confirmed pregnancy among subjects relying on Essure inserts for birth control on the basis of the TVU/HSG algorithm at 1-year post-alternative contraception and to evaluate the intent-to-treat reliance rate 3 months following TVU/HSG confirmation test protocol. The secondary endpoints of the study are to evaluate subject satisfaction with TVU and to evaluate the occurrence of confirmed pregnancy at 10 years among subjects relying on Essure inserts for birth control on the basis of the TVU/HSG algorithm.
Enrollment is complete. Data to be collected will include the following:
a. Reliance rate (complete at time of approval)
b. Pregnancies and outcomes
c. Adverse Events
d. Device removal (added 2016)
|
| Follow-up Visits and Length of Follow-up |
Subjects will be followed for 10 years post-device placement.
|
| Interim or Final Data Summary |
| Interim Results |
There are no planned interim analyses intended to test hypotheses or modify the study. The following information is based on analysis of interim results from the most recent annual study report.
The study protocol was modified in early 2016 to add the capture of device removal events. As of the date of the report (July 27, 2022), all patients not lost to follow-up had reached at least 9 years of follow-up. The cumulative probability of device removal for all subjects for any reason at 9 years is reported as 18.9%. The cumulative probability of device removal for any reason at 9 years for US subjects and OUS subjects is 19.8% and 17.6% respectively.
Limitations: Results summarized are interim data only. The results include data from both inside the US and outside the US. The study was not originally designed to collect data on device removal; as the protocol was modified during the ongoing study, some events were captured retrospectively and patient outcomes data are unavailable. Removals reported in the rate above include all removals, regardless of the reason for removal (for example, adverse event, concomitant with another gynecologic surgery, subject request). Therefore, the removal rates reported do not reflect removals due to device complications alone, which may be a lower rate.
|
