Post-market Study of the Biodesign Hernia Graft

Ventral Hernia Clinical Trial

Official title:

Post-market Study of the Biodesign® Hernia Graft

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04294446
• Other study ID #: 19-004
• Status: Recruiting
• Start date: November 10, 2020
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: Cook Biotech Incorporated
• Contact: Samantha Stevenson, BS
• Phone: 765-497-3385
• Email: sstevenson[@]rtix.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• Biodesign Hernia Graft
The Biodesign Hernia Graft is comprised of 8 layers of decellularized porcine small intestinal submucosa (SIS) that has been pressed-lyophilized (i.e., freeze-dried under vacuum pressure) to laminate the component sheets (i.e., layers) together. In addition, it is perforated and sewn with 4-0 Trisorb suture (polyglycolic acid (PGA); Samyang Corporation, Seoul, South Korea). The suture is distributed in a diamond pattern across the graft and along the periphery and is intended to mitigate delamination of the layers upon rehydration and/or manipulation during implantation. Being a completely biologic device, the Biodesign Hernia Graft is considered MR safe.

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Hospital	Halifax	Nova Scotia
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Cook Biotech Incorporated

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia recurrence	Hernia recurrence through 1-year follow-up	1-year
Secondary	Device-, procedure-, and hernia-related adverse event rates	Summarize the adverse event rates for normal commercial use of the device (e.g., seroma and infection rates)	2-year
Secondary	Hernia recurrence rate through 2-year follow-up	Assess the long-term success of the device in the reinforcement of hernia repairs through 2-year follow-up	2-year
Secondary	Operative times	What was the operation time for the ventral hernia repair?	2-year
Secondary	Hospital stay	Duration of hospital stay	2-year
Secondary	Hospitalization times for related Serious Adverse Events (SAEs)	What was the hospitalization times for any related SAEs?	2-year
Secondary	Patient-reported quality of life: questionaire	Patient-reported quality of life assessed by completion of a questionaire	2-year