At a glance
ClinicalIndex Comparison RecordN/ACompleted· 104 enrolled
Drug / intervention
GORE® BIO-A® Tissue Reinforcementdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biosynthetic Material for Midline Fascial Closure Reinforcement
In Brief
An observational study evaluating GORE® BIO-A® Tissue Reinforcement for Ventral Incisional Hernia. Completed, enrolled 104 participants across 9 sites in 2 countries.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsVentral Incisional Hernia
CountriesNetherlands, United States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedMar 2011
Primary CompletionDec 2014
TodayJul 2026
First PostedMar 30, 2011
Enrollment StartFeb 1, 2011
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.3 years ago
Interventions
GORE® BIO-A® Tissue Reinforcementdevice
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.