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Xenform Postmarket Surveillance Study

NCT01945580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2021-04-14

Study results available
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Summary

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.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

Prolapse Repair

Transvaginal anterior/apical pelvic organ prolapse repair

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Peter Rosenblatt, MD · Mount Auburn Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-10
Primary Completion
2020-02-12
Completion
2020-02-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01945580 on ClinicalTrials.gov