Rebound Hernia Repair Device Mesh Trial
This trial is active, not recruiting.
|Treatments||rebound hrd, standard hernia mesh (vitamesh)|
|Sponsor||Minnesota Medical Development, Inc.|
|Collaborator||University of Kentucky|
|Start date||September 2009|
|End date||March 2012|
|Trial size||70 participants|
|Trial identifier||NCT00968773, Rebound HRD|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Presence of hernia recurrence
time frame: 2 years
Pain and discomfort to patients using VAS
time frame: 2 years
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - 18 to 80 years of age - Unilateral or bilateral inguinal hernia (moderate in size), primary in nature Exclusion Criteria: - 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
|Official title||Rebound Hernia Repair Device Trial|
|Principal investigator||John S Roth, MD|
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