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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Postmarket Surveillance Study


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General
Study Status Progress Adequate
522 Number / Requirement Number PS160001 / PSS001
Study Name Postmarket Surveillance Study
Root Document Number P020014 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Open-label, non-randomized, prospective observational cohort study of two cohorts of subjects who chose to undergo either hysteroscopic sterilization (Essure) or laparoscopic tubal sterilization.



Interim Data Posting

Information regarding interim study progress and results, including the: number of study sites enrolled, number of patients enrolled, baseline characteristics (age, race/ethnicity), rate of Essure device removal, type of removal procedure, and number of women with Essure Confirmation Test, will be posted on the public webpage. An update will occur after 500 women have been enrolled into the Essure study arm, and again after 1,000 women have been enrolled into the Essure study arm. Results for other study endpoints from the 522 order questions (e.g., chronic pelvic pain or abnormal uterine bleeding) will be posted at the completion of the study, due to the statistical methods required for group comparisons.



FDA may also post on its website or otherwise make public postmarket surveillance interim summary data and/or FDA analyses thereof when appropriate to protect the public health, for example when interim results raise safety concerns or may otherwise impact treatment.

Study Population Description The study population will include subjects of reproductive age, between 21 and 45 years of age who have not been pregnant within the past 6 weeks.

The study population will include women who chose to undergo hysteroscopic sterilization (Essure) or laparoscopic tubal sterilization.

Sample Size 2,800 women (1,400 per arm)
Data Collection Main Safety Endpoints:

• Chronic lower abdominal and/or pelvic pain

• Abnormal uterine bleeding (new onset or worsening)

• Hypersensitivity and allergic reactions, and autoimmune disorders (new onset) or autoimmune- like reactions

• Invasive gynecologic surgery including Essure insert removal

Secondary Safety Endpoints:

• Other adverse events

• In the event of a device removal or event of interest, additional data collection may include bloodwork, pathology, histology, and metallurgic testing, as appropriate

Effectiveness:

• Pregnancy

Follow-up Visits and Length of Follow-up Follow-up measures will include adverse event assessment, medical history including gynecological procedures, patient reported outcome (PRO) measures for chronic pelvic pain and abnormal uterine bleeding, bloodwork for women with certain adverse events, and analysis of removed Essure devices.

36 months

Study Interim or Final Data Summary
Actual Number of Patients Enrolled As of May 3, 2017, 1 patient has been enrolled.



Actual Number of Sites Enrolled As of May 3, 2017, 60 sites have been selected for participation, 31 sites have submitted IRB applications, 24 sites have received central IRB approval, and 3 sites have been enrolled.



Postmarket Surveillance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
study plan report 03/30/2016 03/29/2016 On Time
6 month report 03/03/2017 03/03/2017 On Time
1 year report 09/02/2017    
18 month report 03/03/2018    
2 year report 09/02/2018    
3 year report 09/02/2019    
4 year report 09/01/2020    
5 year report 09/01/2021    
6 year report 09/01/2022    
Final report 09/01/2023    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-2252
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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