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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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POP AE and Effectiveness rates, registry


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS120081 / PSS002
Date Current Plan Accepted 02/20/2015
Study Name POP AE and Effectiveness rates, registry
Root Document Number K060984 
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 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 09/28/2015 Overdue/Received
3 year report 09/26/2016 09/26/2016 On Time
4 yr report 09/26/2017 09/22/2017 On Time
5 yr report 09/26/2018 09/26/2018 On Time
6 year report 09/20/2019 09/20/2019 On Time
Final report 06/26/2020 11/02/2020 Overdue/Received


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