Clinical Trials Logo
  1. Home
  2. Ventral Incisional Hernia
  3. NCT01325792

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

Ventral Incisional Hernia Clinical Trial

Official title:
Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biosynthetic Material for Midline Fascial Closure Reinforcement

Clinical Trial 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.

Clinical Trial Description

The study will evaluate the performance of the biosynthetic mesh when used to reinforce the midline fascial closure in single-staged open complex ventral incisional hernia repair. It is designed to test the null hypothesis that the two year recurrence rate associated with the device is greater than or equal to 50% vs the alternative hypothesis that the two year recurrence rate is less than 50%. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01325792
Study type Observational
Source W.L.Gore & Associates
Contact
Status Completed
Phase N/A
Start date February 2011
Completion date December 2014
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03034213 - Gentrix™ Versus Biological or Prosthetic Mesh N/A
Enrolling by invitation NCT06306976 - Shear-Wave Elastography N/A
Not yet recruiting NCT06183840 - Only Mesh Fixation With Glue of Ventral/Incisional Laparoscopic Hernia Repair N/A
Completed NCT02206828 - The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
Not yet recruiting NCT04624100 - Quality Control of Ventral Hernia Surgery by Prospective Registration
Active, not recruiting NCT03324854 - Use of Mosquito Net Mesh for Ventral Hernia Repair N/A
Not yet recruiting NCT05575141 - Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias N/A
Terminated NCT03317665 - Observational Biologic or Prosthetic Mesh
Recruiting NCT05576753 - Preperitoneal Umbilical Mesh Area N/A
Completed NCT05142761 - Tension in Posterior Component Separation for Abdominal Wall Reconstruction
Recruiting NCT03255239 - Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias N/A
Completed NCT03043079 - Ultrasound Assessment of Ventral Hernia Defects N/A
Completed NCT02129140 - Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)