Post-market Study of the Biodesign Hernia Graft

Post-market Study of the Biodesign® Hernia Graft

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.

Study Overview

• Status: Recruiting
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Biodesign Hernia Graft

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 Type: Observational
• Enrollment (Estimated): 95

Contacts and Locations

• Study Contact: Name: Samantha Stevenson, BS; Phone Number: 765-497-3385; Email: sstevenson@rtix.com
• Study Contact Backup: Name: Jason Hodde, MS; Phone Number: 765-497-3385; Email: jhodde@rtix.com

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Recruiting
      • St. Paul's Hospital
      • Contact: Jerry Liu; Phone Number: 604-682-2344; Email: jliu4@providencehealth.bc.ca
      • Principal Investigator: Manoj Raval, MD
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Recruiting
      • Queen Elizabeth II Hospital
      • Principal Investigator: Samuel Minor, MD
      • Contact: Lisa Julien, RN; Phone Number: 902-473-3877; Email: lisa.julien@nshealth.ca
• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Joan Kaiser, RN; Phone Number: 615-343-5821; Email: joan.l.kaiser@vumc.org
      • Principal Investigator: Richard Pierce, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients who meet all of the inclusion criteria and none of the exclusion criteria will be invited to participate in this study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia recurrence	Hernia recurrence through 1-year follow-up	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Operative times	What was the operation time for the ventral hernia repair?	2-year
Hospital stay	Duration of hospital stay	2-year
Hospitalization times for related Serious Adverse Events (SAEs)	What was the hospitalization times for any related SAEs?	2-year
Patient-reported quality of life: questionaire	Patient-reported quality of life assessed by completion of a questionaire	2-year

Collaborators and Investigators

• Sponsor: Cook Biotech Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 19-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No