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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 PS120006 / PSS001
Current Plan Approved 11/12/2013
Study Name POP AE and Effectiveness rates, registry
Root Document Number K082730  K121612 
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, multi-center, postmarket cohort study designed to evaluate the long-term efficacy and safety of the Elevate Apical/Posterior Prolapse Repair System compared to Native Tissue Repair in the treatment of posterior or posterior/apical vaginal prolapse in females at least 18 years of age. The study will enroll an equal number of

subjects into the Elevate and native tissue repair groups. The treating surgeon together with the

subject will decide which treatment the subject will receive.

There are two primary (non-inferiority efficacy and non-inferiority safety) objectives in this

study. Both primary objectives need to be met for this study to be considered successful. The primary superiority efficacy objective will be evaluated only if the primary non-inferiority efficacy objective is met. The secondary efficacy objective will be evaluated for non-inferiority

and superiority following the same analysis methods as for the primary efficacy objective and it will only be evaluated after the primary non-inferiority efficacy objective is met."

Study Population Description Women implanted with Elevate Apical/Posterior Prolapse Repair Systems and women who underwent traditional native tissue repair (NTR).
Sample Size 494 subjects (247 patients treated with Elevate Apical/Posterior Prolapse Repair System and 247 patients treated with Native Tissue Repair) will be enrolled at up to 40 study centers
Data Collection Primary Endpoints: 1. Primary efficacy endpoint of surgical treatment "success" or "failure┬┐; 2. Rate of device or procedural related serious adverse events through 36 months post primary prolapse repair. Secondary Endpoints: 1. Secondary efficacy endpoint of surgical treatment "success" or "failure┬┐; 2. Rate of repeat/revision surgery; 3. Changes in QoL captured at baseline through 36 months.
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 11/15/2013 11/15/2013 On Time
1 yr report 05/17/2014 04/28/2014 On Time
18 month report 11/15/2014 10/27/2014 On Time
2 yr report 05/17/2015 04/24/2015 On Time
3 yr report 05/16/2016    
4 yr report 05/16/2017    
5 yr report 05/16/2018    


  • 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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