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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 03/11/2016
Study Name POP AE and Effectiveness rates, registry
Root Document Number K041140 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Design: This is a multicenter, non-randomized, cohort study of MatriStem Pelvic Floor Matrix for the

treatment of transvaginal repair of POP among patients with clinically documented POP and symptomatic

POP.



Primary Objectives:



For safety, to compare the proportion of subjects noting pelvic pain in the MatriStem Pelvic Floor Matrix Group to the proportion of subjects noting pelvic pain in the non-mesh repair (NTR) Group following surgical treatment for POP. The absence of pelvic pain is defined as a subject who has not had the AE of pelvic pain reported beyond 12 weeks post-operative or, the SAE of pelvic pain reported immediately postoperative and beyond.



For effectiveness, to compare the proportion of surgical success in the MatriStem Pelvic Floor Matrix Group to the proportion of surgical success in the NTR Group following surgical treatment for POP. Surgical success is a composite effectiveness outcome that includes anatomic success, subjective success, and no retreatment for POP.



Secondary Objective:



The secondary objective is to track additional safety, effectiveness, and quality of life outcome measures in subjects undergoing surgical and non-surgical (pessary use) treatment for POP. This entails the capture of comprehensive data that includes those elements required by the FDA's requirement for post- marketing surveillance of transvaginal mesh use for POP.



Study Population Description Qualifying consecutive adult female subjects (18 years of age and older) will be screened according to the inclusion and exclusion criteria.
Sample Size Pelvic pain and surgical success were selected to be the co-primary safety and effectiveness endpoints, respectively, of the study. Assuming that the NTR control group has a pelvic pain rate of 57% [Columbo et al. 2000] and the mesh group has a pelvic pain rate of 40% [Carey et al. 2009], a total of 126 subjects are needed in order to demonstrate non-inferiority of the mesh at an 8% non-inferiority margin at 80% power for a one-sided 0.025 significance level. Assuming that the NTR control group has a surgical success rate of 90% and the mesh group has a rate of 90%, a total of 126 subjects are needed in order to demonstrate non - inferiority of the mesh at a 15% non -inferiority margin [Barber et al. 2009] at 80% power with a one-sided 0.025 significance level. In order to meet the sample size requirements for both endpoints, a total of 126 subjects are required. After adjusting for a 22% dropout rate [Miller et al. 2011] at the three year time point, a total of 162 subjects will be enrolled in the study.



The sponsor estimates 7 to 10 Investigational Sites will be entered into the study to enroll all subjects in a 3- year total enrollment period.

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 total length of follow-up is 36 months. Follow-up visits are scheduled at 6,12, 18, 24 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 09/04/2015 On Time
3 yr report 09/07/2016 09/07/2016 On Time


  • 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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