Rebound Hernia Repair Device Mesh Trial
Status unconfirmed · Phase 4
Conditions studied: Inguinal Hernia
In brief
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 Hernia Repair Device will be used for its approved indication in comparison to "standard" hernia mesh. Two-way students t-tests, Chi squared analysis and ANOVA will be used to detect differences in variables. The study is sufficiently powered to detect a 25% difference. The study data will include quality of life assessments, visual analogue scale , SF-36, Carolinas Comfort Scale), recurrence of hernia (technical failure), use of medications (pain) and complications/adverse events.
Key facts
- Study ID
- NCT00968773
- Run by
- Minnesota Medical Development, Inc.
- People needed
- 70
- Starts
- 2009-09-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2016-03-15
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18 to 80 years of age
- Unilateral or bilateral inguinal hernia (moderate in size), primary in nature
You may not qualify if…
- 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
Where it is running
- University of Kentucky Dept. Of Surgery — Lexington, Kentucky, United States
- The Ohio State Medical Center, Dept. of Surgery — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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