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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Post Approval Study


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General
Study Status Progress Adequate
Application Number P020014 S041/ PAS001
Date Current Protocol Accepted 04/28/2016
Study Name Post Approval Study
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 Design Description 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 Description Women, aged 21 to 44 years of age, seeking permanent contraception
Sample Size 620 patients were enrolled.
Data Collection 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 Safety Information 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, 2018), all patients not lost to follow-up had reached at least 5 years of follow-up. The cumulative probability of device removal for all subjects is reported as 8.6%. The cumulative probability of device removal for US subjects and OUS subjects is 6.8% and 10.9% 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).



Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 07/28/2016 07/28/2016 On Time
two year report 07/28/2017 07/28/2017 On Time
three year report 07/28/2018 07/27/2018 On Time
four year report 07/28/2019 07/26/2019 On Time
five year report 07/28/2020    
six year report 07/28/2021    
seven year report 07/28/2022    
Final report 07/28/2023    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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