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

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