Clinical Trial: Rebound Hernia Repair Device Mesh Trial

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Rebound Hernia Repair Device Trial

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 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.

Detailed Summary:
Sponsor: Minnesota Medical Development, Inc.

Current Primary Outcome: Presence of hernia recurrence [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Pain and discomfort to patients using VAS [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: Minnesota Medical Development, Inc.

Dates:
Date Received: August 27, 2009
Date Started: September 2009
Date Completion: September 2013
Last Updated: March 14, 2016
Last Verified: September 2009