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Completed Not applicable Interventional Results available

Xenform Postmarket Surveillance Study

ClinicalTrials.gov ID: NCT01945580

Public ClinicalTrials.gov record NCT01945580. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Non-Randomized, Parallel Cohort, Multi-Center Study of Xenform vs. Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.

Study identification

NCT ID
NCT01945580
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Boston Scientific Corporation
Industry
Enrollment
374 participants

Conditions and interventions

Interventions

Procedure

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 10, 2014 (Actual)
Primary completion
Feb 12, 2020 (Actual)
Completion
Feb 12, 2020 (Actual)
Last update posted
Apr 14, 2021

2014 – 2020

United States locations

U.S. sites
25
U.S. states
15
U.S. cities
24
Facility City State ZIP Site status
University of California, Irvine Medical Center Orange California 92868 —
Emory Hospital Atlanta Georgia 30322 —
Augusta University Augusta Georgia 30912 —
Cherokee Womens Health Specialist Canton Georgia 30114 —
NorthShore University Health System Skokie Illinois 60076 —
Acadia Women's Health Crowley Louisiana 70526 —
Chesapeake Urology Research Associates Hanover Maryland 21061 —
Chesapeake Urology Research Associates Owings Mills Maryland 21117 —
Mount Auburn Hospital Cambridge Massachusetts 02138 —
Beyer Research Kalamazoo Michigan 49009 —
Cooper University Hospital Voorhees Township New Jersey 08043 —
University of Buffalo Buffalo New York 14222 —
Beth Israel Medical Center New York New York 10003 —
NYU Langone Medical Center New York New York 10016 —
University of North Carolina Chapel Hill North Carolina 27599 —
Carolina Urology Partners Gastonia North Carolina 28054 —
Lyndhurst Clinical Research Winston-Salem North Carolina 27103 —
Prime Care of SEO Dresden Ohio 43821 —
Prisma Health System Greenville South Carolina 29605 —
Southern Urogynecology West Columbia South Carolina 29169 —
Center for Pelvic Health Franklin Tennessee 37067 —
Practice Research Organization Dallas Texas 75230 —
Houston Metro Urology Houston Texas 77030 —
Las Colinas ObGyn Irving Texas 75062 —
MultiCare Women's Health Care Covington Washington 98042 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01945580, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 14, 2021 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01945580 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →