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Rebound Hernia Repair Device Mesh Trial

NCT00968773 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-03-15

No results posted yet for this study

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.

Conditions

  • Inguinal Hernia

Interventions

DEVICE

Rebound HRD

Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation

DEVICE

Standard hernia mesh (VitaMesh)

Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation

Sponsors & Collaborators

  • University of Kentucky

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Minnesota Medical Development, Inc.

    lead INDUSTRY

Principal Investigators

  • John S Roth, MD · University of Kentucky

  • Jeffrey W Hazey, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-03-31
Completion
2013-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00968773 on ClinicalTrials.gov