Status:
UNKNOWN
Rebound Hernia Repair Device Mesh Trial
Lead Sponsor:
Minnesota Medical Development, Inc.
Collaborating Sponsors:
University of Kentucky
Ohio State University
Conditions:
Inguinal Hernia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This is a post-market study of the Rebound Hernia Repair Device to further establish the safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population. The Rebound Herni...
Eligibility Criteria
Inclusion
- 18 to 80 years of age
- Unilateral or bilateral inguinal hernia (moderate in size), primary in nature
Exclusion
- Unable to provide informed consent
- Assessed as ASA 3 or 4
- Renal failure;creatinine greater than 2.0mg percent
- Ascites as determined by clinical suspicion/ultrasound confirmation
- Known pregnancy
- Femoral hernias
- Diabetes requiring injectable insulin
- Prior lower abdominal surgery through lower midline or Pfannenstiel incision
- TAPP approach
- Requiring anticoagulants during surgery
- Participation in another study involving another device or drug
- Emergent procedures for hernia incarceration and strangulation
- Recurrent inguinal hernias
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00968773
Start Date
September 1 2009
End Date
September 1 2013
Last Update
March 15 2016
Active Locations (2)
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1
University of Kentucky Dept. Of Surgery
Lexington, Kentucky, United States, 40536-0293
2
The Ohio State Medical Center, Dept. of Surgery
Columbus, Ohio, United States, 43210-1228