Post-market Study of the Biodesign Hernia Graft

Recruiting

• Conditions: Ventral Hernia

• Registration Number: NCT04294446
• Lead Sponsor: Cook Biotech Incorporated

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-04
• Study Start: 2020-11-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft

Exclusion Criteria

1. Known sensitivity to porcine material

   For the study, the following patients will also be excluded:

2. Age < 18 years

3. Unable or unwilling to provide informed consent

4. Life expectancy of less than one year from the date of the index procedure

5. Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hernia recurrence	1-year	Hernia recurrence through 1-year follow-up

Secondary Outcome Measures

Name	Time	Method
Operative times	2-year	What was the operation time for the ventral hernia repair?
Hernia recurrence rate through 2-year follow-up	2-year	Assess the long-term success of the device in the reinforcement of hernia repairs through 2-year follow-up
Patient-reported quality of life: questionaire	2-year	Patient-reported quality of life assessed by completion of a questionaire
Device-, procedure-, and hernia-related adverse event rates	2-year	Summarize the adverse event rates for normal commercial use of the device (e.g., seroma and infection rates)
Hospitalization times for related Serious Adverse Events (SAEs)	2-year	What was the hospitalization times for any related SAEs?
Hospital stay	2-year	Duration of hospital stay

Trial Locations

Locations (3)

Queen Elizabeth II Hospital; 🇨🇦 Halifax, Nova Scotia, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States