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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ESS-305


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General
Application Number P020014 S012/ PAS001
Current Plan Approved 06/15/2007
Study Name ESS-305
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 Design Description This is an observational cohort study. A new cohort of patients and physicians will be enrolled to collect procedural data on ESS305. Data from the Study for Newly Trained Physicians (completed September 2005) will be used as the comparator. The protocol also includes collection of adverse events data.The purpose of this post-approval clinical study is to determine the following: 1. Bilateral placement ofthe ESS305 micro-insert at first attempt; 2. Comparison of bilateral placement success between NewlyTrained physicians and Experienced physicians

3. Identification of factors predictive of failure to achieve bilateral placement ofthe ESS305 micro-insert al first attempt; 4. Evaluation of aspects ofthe ESS305 design that may impact

bilateral placement rate; 5. Hysteroscopy time to perform the procedure 6. Adverse device effects; and 7. Adverse procedure events.
Study Population Description Study population is 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 657 women enrolled - protocol states 20 sites enrolled patients
Data Collection Study endpoints include: (1) bilateral micro-insert placement rate, (2) identification of factors predictive of micro-insert placement failure, (3) evaluation of aspects of the ESS305 design that may impact bilateral placement rate; and (4) hysteroscopy time to perform the procedure.
Follow-up Visits and Length of Follow-up N/A
Final Study Results
Interim Safety Information Study is completed. See Final Results
Number of Patients 584 women
Number of Sites 76
Follow-up Rate 81.60%
Safety Findings The sponsor reported only 6 adverse events occurred during and after the Essure placement procedure (6 out of 584). All reported events were minor with the exception of one case. The subject was hospitalized after hysteroscopy resulted in a uterine perforation by the hysteroscope. The sponsor claims the Essure device did not cause the injury to the patient. None of these events represent unanticipated adverse device effects.
Strengths & Weaknesses The study is well designed to evaluate the placement rate among newly trained physicians at first attempt, when implanting the device in women seeking permanent sterilization.
Label Changes Update labeling with the results of the study in the context of patient and physician labeling.


ESS-305 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/14/2007 12/14/2007 On Time
1 year report 06/14/2008 06/17/2008 Overdue/Received
18 month report 12/13/2008 12/15/2008 Overdue/Received
Final Report 06/14/2009 06/16/2009 Overdue/Received


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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