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Rebound Hernia Repair Device Mesh Trial

Primary Purpose

Inguinal Hernia

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rebound HRD
Standard hernia mesh (VitaMesh)
Sponsored by
Minnesota Medical Development, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring inguinal hernia, mesh, hernia repair device

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kentucky Dept. Of Surgery
  • The Ohio State Medical Center, Dept. of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The Rebound hernia repair device with no fixation

Standard Hernia Mesh using fixation

Arm Description

Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature.

Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature.

Outcomes

Primary Outcome Measures

Presence of hernia recurrence

Secondary Outcome Measures

Pain and discomfort to patients using VAS

Full Information

First Posted
August 27, 2009
Last Updated
March 14, 2016
Sponsor
Minnesota Medical Development, Inc.
Collaborators
University of Kentucky, Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT00968773
Brief Title
Rebound Hernia Repair Device Mesh Trial
Official Title
Rebound Hernia Repair Device Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Minnesota Medical Development, Inc.
Collaborators
University of Kentucky, Ohio State University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
inguinal hernia, mesh, hernia repair device

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The Rebound hernia repair device with no fixation
Arm Type
Experimental
Arm Description
Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature.
Arm Title
Standard Hernia Mesh using fixation
Arm Type
Active Comparator
Arm Description
Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature.
Intervention Type
Device
Intervention Name(s)
Rebound HRD
Intervention Description
Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation
Intervention Type
Device
Intervention Name(s)
Standard hernia mesh (VitaMesh)
Other Intervention Name(s)
VitaMesh
Intervention Description
Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation
Primary Outcome Measure Information:
Title
Presence of hernia recurrence
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Pain and discomfort to patients using VAS
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S Roth, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey W Hazey, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Dept. Of Surgery
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States
Facility Name
The Ohio State Medical Center, Dept. of Surgery
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1228
Country
United States

12. IPD Sharing Statement

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Rebound Hernia Repair Device Mesh Trial

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