Rebound Hernia Repair Device Mesh Trial

March 14, 2016 updated by: Minnesota Medical Development, Inc.

Rebound Hernia Repair Device Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • University of Kentucky Dept. Of Surgery
    • Ohio
      • Columbus, Ohio, United States, 43210-1228
        • The Ohio State Medical Center, Dept. of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • VitaMesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of hernia recurrence
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain and discomfort to patients using VAS
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minnesota Medical Development, Inc.

Collaborators

Ohio State University
University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ANTICIPATED)

March 1, 2012

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

August 27, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (ESTIMATE)

August 31, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rebound HRD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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