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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

 

 

 

 

            

POP AE and Effectiveness rates, registry


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General
522 Number / Requirement Number PS120001 / PSS001
Current Plan Approved 03/07/2014
Study Name POP AE and Effectiveness rates, registry
Root Document Number K041140 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a multicenter, non-randomized, cohort study of MatriStem Pelvic Floor for the treatment of transvaginal repair of POP among patients with clinically documented POP and symptomatic POP. N The primary study hypothesis is that at one year following surgical treatment for POP, the proportion of subjects reporting the absence of pelvic pain will be non-inferior to the proportion of subjects reporting the absence of pelvic pain in the NTR group. Secondarily, it is hypothesized that the proportion of prolapse recurrence in the MatriStem Pelvic Floor Matrix Group will be non-inferior to the proportion of prolapse recurrence in the NTR group at 36 months following surgical treatment for POP.

Study Population Description Subjects with clinically documented POP and symptomatic POP that will undergo surgical or non-surgical treatment.
Sample Size 162 subjects (81 patients treated with MatriStem Pelvic Floor Matrix and 82 patients treated with Native Tissue Repair as controls) will be enrolled at 7-10 study centers
Data Collection Primary Effectiveness Endpoint: Surgical success/failure at 36 months; Primary Safety Ednpoint: Rate of serious adverse event of pelvic pain (beginning immediately postoperative) and adverse event of pelvic pain (beyond 12 weeks postoperative) that is device or procedure related as determined by independent adjudication; Secondary Endpoints: 1. Composite outcome of surgical success based on an alternate anatomic criteria at 36 months; 2. Quality of Life at baseline and 6, 12, 18, 24, 36 months; 3. Cumulative rates and severity of adverse events evaluated at 6, 12, 18, 24, and 36 months following the index procedure.
Follow-up Visits and Length of Follow-up The length of study follow-up is 3 years. Follow-up will be conducted at 3 months, 6 months, 12 months, 18 months, 24 months and 36 months.


POP AE and Effectiveness rates, registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/09/2014 03/10/2014 Overdue/Received
1 year report 09/08/2014 09/08/2014 On Time
18 month report 03/09/2015 03/09/2015 On Time
2 yr report 09/08/2015    
3 yr report 09/07/2016    


  • 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
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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