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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
Sponsor:
Collaborators:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Inguinal Hernia Device: Rebound HRD Device: Standard hernia mesh (VitaMesh) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rebound Hernia Repair Device Trial
Study Start Date : September 2009
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Presence of hernia recurrence [ Time Frame: 2 years ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
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
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

Responsible Party: Steve Nuss Chief Marketing Officer, Minnesota Medical Development, Inc.
ClinicalTrials.gov Identifier: NCT00968773     History of Changes
Other Study ID Numbers: Rebound HRD
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: September 2009

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