Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
95 participants
OBSERVATIONAL
2020-11-10
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
ALL
Yes
Sponsors
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Cook Biotech Incorporated
INDUSTRY
Responsible Party
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Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
St. Paul's Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Hospital
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Joan Kaiser, RN
Role: primary
Jerry Liu
Role: primary
Lisa Julien, RN
Role: primary
Other Identifiers
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19-004
Identifier Type: -
Identifier Source: org_study_id