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Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study

NCT01378065 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2020-05-12

Study results available
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Summary

This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.

Conditions

  • Pelvic Organ Prolapse (POP)

Interventions

DEVICE

Restorelle Direct Fix A&P

Restorelle Direct Fix A\&P is a permanently implantable synthetic mesh for reconstruction of the pelvic floor secondary to the prolapse or protrusion of the pelvic organs into or out of the vaginal canal.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Barry Jarnagin, MD · Center for Pelvic Health, Franklin, TN, United States

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-09-30
Completion
2013-09-30

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 NCT01378065 on ClinicalTrials.gov