Rebound Hernia Repair Device Mesh Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Minnesota Medical Development, Inc..
Recruitment status was  Recruiting
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014