MedTrace Logo

Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement

NCT01325792 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2015-12-24

Study results available
· View outcomes & findings →

Summary

Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair.

Conditions

  • Ventral Incisional Hernia

Interventions

DEVICE

GORE® BIO-A® Tissue Reinforcement

Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Michael Rosen, MD · University Hospitals Cleveland Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

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 NCT01325792 on ClinicalTrials.gov