NCT00968773

Rebound Hernia Repair Device Mesh Trial

Rebound Hernia Repair Device Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Minnesota Medical Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
DEVICE	Rebound HRD	Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation
DEVICE	Standard hernia mesh (VitaMesh)	Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-03-01
• Completion: 2013-09-01
• First posted: 2009-08-31
• Last updated: 2016-03-15

Locations

2 sites across 1 country: United States