Rebound Hernia Repair Device Mesh Trial
This study is currently recruiting participants.
Verified September 2009 by Minnesota Medical Development, Inc.
Sponsor:
Minnesota Medical Development, Inc.
Collaborators:
University of Kentucky
Ohio State University
Information provided by:
Minnesota Medical Development, Inc.
ClinicalTrials.gov Identifier:
NCT00968773
First received: August 27, 2009
Last updated: September 18, 2009
Last verified: September 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Inguinal Hernia |
Device: Rebound HRD Device: Standard hernia mesh (VitaMesh) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Rebound Hernia Repair Device Trial |
Resource links provided by NLM:
Genetics Home Reference related topics:
abdominal wall defect
MedlinePlus related topics:
Hernia
U.S. FDA Resources
Further study details as provided by Minnesota Medical Development, Inc.:
Primary Outcome Measures:
- Presence of hernia recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain and discomfort to patients using VAS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: Rebound HRD
|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968773
Contacts
| Contact: John S Roth, MD | 859-323-6346 | jsroth2@uky.edu |
| Contact: Rebecca Shelton, BSN, CCRP | 859-323-6346 ext 246 | rshel1@email.uky.edu |
Locations
| United States, Kentucky | |
| University of Kentucky Dept. Of Surgery | Recruiting |
| Lexington, Kentucky, United States, 40536-0293 | |
| Contact: Roth | |
| Contact: Shelton | |
| Principal Investigator: John S Roth, MD | |
| Sub-Investigator: Paul A Kearney, MD | |
| Sub-Investigator: Richard W Schwartz, MD | |
| Sub-Investigator: Phillip K Chang, MD | |
| Sub-Investigator: Andrew C Bernard, MD | |
| Sub-Investigator: Bernard R Boulanger, MD | |
| United States, Ohio | |
| The Ohio State Medical Center, Dept. of Surgery | Recruiting |
| Columbus, Ohio, United States, 43210-1228 | |
| Contact: Jeffrey W Hazey, MD 614-293-3346 jeffrey.hazey@osumc.edu | |
| Contact: Rebecca Dettorre 614-293-8549 becky.dettorre@osumc.edu | |
| Sub-Investigator: Vimal K Narula, MD | |
Sponsors and Collaborators
Minnesota Medical Development, Inc.
University of Kentucky
Ohio State University
Investigators
| Principal Investigator: | John S Roth, MD | University of Kentucky |
| Principal Investigator: | Jeffrey W Hazey, MD | Ohio State University |
More Information
No publications provided
| Responsible Party: | Steve Nuss Chief Marketing Officer, Minnesota Medical Development, Inc. |
| ClinicalTrials.gov Identifier: | NCT00968773 History of Changes |
| Other Study ID Numbers: | Rebound HRD |
| Study First Received: | August 27, 2009 |
| Last Updated: | September 18, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Minnesota Medical Development, Inc.:
|
inguinal hernia mesh hernia repair device |
Additional relevant MeSH terms:
|
Hernia Hernia, Inguinal Pathological Conditions, Anatomical Hernia, Abdominal |
ClinicalTrials.gov processed this record on May 21, 2013