Status:
COMPLETED
Inguinal Hernia Study Using Biodesign IHM
Lead Sponsor:
Cook Group Incorporated
Collaborating Sponsors:
Cook Biotech Incorporated
MED Institute, Incorporated
Conditions:
Inguinal Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), ran...
Eligibility Criteria
Inclusion
- 18 years of age
- Diagnosis of Unilateral inguinal hernia repair
- Able to provide written consent
Exclusion
- Incarcerated hernia
- Allergic or religious beliefs that disallow porcine material
- Previous hernia repair on the designated hernia site
- Class IV or V anesthesia requirements
- Bowel obstruction
- Peritonitis
- Life expectancy \< 3 years
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00393887
Start Date
March 1 2007
End Date
June 1 2014
Last Update
November 20 2015
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201