Post-market Study of the Biodesign Hernia Graft

Status Recruiting

Clinical Trial Summary

The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.

Clinical Trial Description

This multicenter, open-label, prospective clinical study will evaluate the performance of the Biodesign Hernia Graft to reinforce soft tissues during ventral hernia repair. This post-market study will enroll up to 95 patients at up to 10 clinical sites. Each clinical site will be limited to a maximum of 50 patients to ensure a variety of patients and surgical techniques are represented. There is no minimum enrollment number per site. This study has been designed as a multicenter, open-label, prospective study to collect data on the performance of the Biodesign Hernia Graft. The inclusion and exclusion criteria for this study have been selected based on the instructions outlined in the IFU so that the results from this study can provide data on the real-world use of the device. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04294446
Study type	Observational
Source	Cook Biotech Incorporated
Contact	Samantha Stevenson, BS
Phone	765-497-3385
Email	sstevenson@rtix.com
Status	Recruiting
Phase
Start date	November 10, 2020
Completion date	June 30, 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06016426` - Mass Closure vs Layer by Layer Closure	N/A
Recruiting	`NCT05572021` - A Comparison of the Outcomes in Fortiva and Strattice Mesh	N/A
Completed	`NCT02292264` - Risk Factors and Complications of Ventral Hernia Repair
Completed	`NCT02263625` - Regional Differences In Indication for Ventral Hernia Repair
Completed	`NCT02263599` - Conservative Treatment For Ventral Hernia
Completed	`NCT01961687` - A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.	N/A
Completed	`NCT01325246` - Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair	N/A
Completed	`NCT03283982` - Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM	N/A
Not yet recruiting	`NCT05526209` - Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia
Completed	`NCT04438369` - Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair.	N/A
Recruiting	`NCT04173884` - Video-based Collaborative Learning to Improve Ventral Hernia Repair	N/A
Recruiting	`NCT02703662` - Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction	Phase 2/Phase 3
Completed	`NCT03938688` - Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation	N/A
Completed	`NCT01719718` - The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair	N/A
Completed	`NCT03342040` - Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair	N/A
Completed	`NCT04150796` - Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernias	N/A
Recruiting	`NCT03222102` - Ventral Hernia Prevention After Liver Transplantation	N/A
Completed	`NCT05610267` - Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Terminated	`NCT01794338` - The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients	N/A
Completed	`NCT01886963` - A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair	N/A