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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 PS120081 / PSS002
Current Plan Approved 02/20/2015
Study Name POP AE and Effectiveness rates, registry
Root Document Number K060984 
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 prospective, non-randomized, parallel cohort, multi-center study to compare transvaginal repair with XenForm (a biologic mesh) to traditional native tissue repair in women surgically treated for anterior/apical pelvic organ prolapse with or without concurrent cystocele. The study is using the Pelvic Floor Disorders Outcome Registry (PFD Registry).

Study Population Description Subjects who undergo a medical intervention (surgical or non-surgical) to treat recurrence, persistence of pelvic organ prolapse or a treatment complication
Sample Size 454 subjects (227 patients treated with Xenform Soft Tissue Repair Matrix and 227 patients treated with Native Tissue Repair as controls) will be enrolled at up to 30 study centers
Data Collection Primary Endpoints: 1. Non-inferiority of transvaginal repair with Xenform over native tissue repair at 36 months as compared to baseline; 2. Non-inferiority of Xenform to native tissue repair for safety by comparing rates of serious device or serious procedure related complications between baseline and the 36 month time point. Secondary Endpoints: 1. Incidence of Xenform erosion; 2. Incidence of Xenform exposure; 3. Incidence of de novo dyspareunia; 4. Improvement in subject specific outcomes at 36 months compared to Baseline (pelvic floor symptoms (PFDI-20), QOL (PFIQ-7), change in sexual functioning (PISQ-12), TOMUS pain scale); 5. Assessment of subject¿s level of improvement, measured by the Patient Global Impression of Improvement for Prolapse (PGI-I for Prolapse); 6. Absence of re-intervention or re-surgery for recurrence or persistence of POP or Xenform exposure/erosion; 7. Surgical success; 8. Device or procedure related incidence of the following: pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation and/or de novo voiding dysfunction.
Follow-up Visits and Length of Follow-up The length of study follow-up is 3 years. Follow-up will be conducted at 2 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 03/28/2014 03/28/2014 On Time
1 yr report 09/27/2014 09/25/2014 On Time
18 month report 03/28/2015 03/31/2015 Overdue/Received
2 yr report 09/27/2015    
3 yr report 09/26/2016    
4 yr report 09/26/2017    
5 yr report 09/26/2018    
Final report 02/26/2019    


  • 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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