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Inguinal Hernia Study Using Biodesign IHM

NCT00393887 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-11-20

Study results available
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Summary

Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.

Conditions

  • Inguinal Hernia

Interventions

DEVICE

Biodesign IHM

Biodesign IHM is placed to reinforce the hernia repair

DEVICE

Polypropylene mesh

Polypropylene mesh is used to reinforce the hernia repair.

Sponsors & Collaborators

  • Cook Biotech Incorporated

    collaborator INDUSTRY

  • MED Institute, Incorporated

    collaborator INDUSTRY

  • Cook Group Incorporated

    lead INDUSTRY

Principal Investigators

  • Tracy Timmons, M.D. · University of Maryland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

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 NCT00393887 on ClinicalTrials.gov