Rebound Hernia Repair Device Mesh Trial
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|ClinicalTrials.gov Identifier: NCT00968773|
Recruitment Status : Unknown
Verified September 2009 by Minnesota Medical Development, Inc..
Recruitment status was: Active, not recruiting
First Posted : August 31, 2009
Last Update Posted : March 15, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Inguinal Hernia||Device: Rebound HRD Device: Standard hernia mesh (VitaMesh)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Rebound Hernia Repair Device Trial|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||September 2013|
Experimental: The Rebound hernia repair device with no fixation
Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature.
Device: Rebound HRD
Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation
Active Comparator: Standard Hernia Mesh using fixation
Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature.
Device: Standard hernia mesh (VitaMesh)
Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation
Other Name: VitaMesh
- Presence of hernia recurrence [ Time Frame: 2 years ]
- Pain and discomfort to patients using VAS [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968773
|United States, Kentucky|
|University of Kentucky Dept. Of Surgery|
|Lexington, Kentucky, United States, 40536-0293|
|United States, Ohio|
|The Ohio State Medical Center, Dept. of Surgery|
|Columbus, Ohio, United States, 43210-1228|
|Principal Investigator:||John S Roth, MD||University of Kentucky|
|Principal Investigator:||Jeffrey W Hazey, MD||Ohio State University|