Rebound Hernia Repair Device Mesh Trial

Sponsor

Minnesota Medical Development, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00968773

Collaborator

University of Kentucky (Other), Ohio State University (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Sep 1, 2009

Anticipated Primary Completion Date :

Mar 1, 2012

Anticipated Study Completion Date :

Sep 1, 2013

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 Names: VitaMesh

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

Outcome Measures

Primary Outcome Measures

Presence of hernia recurrence [2 years]

Secondary Outcome Measures

Pain and discomfort to patients using VAS [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky Dept. Of Surgery	Lexington	Kentucky	United States	40536-0293
2	The Ohio State Medical Center, Dept. of Surgery	Columbus	Ohio	United States	43210-1228