Study of Surgical Mesh for Inguinal Hernia Repair

October 1, 2010 updated by: Biomerix

Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique

The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary, unilateral, open inguinal hernia repair.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

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
    • Nebraska
      • Omaha, Nebraska, United States, 68178
        • Creighton University
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey Veterans Affairs Medical Center

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male ≥19 years old
  • symptomatic and palpable inguinal hernia
  • candidate for unilateral, primary, open inguinal hernia repair using the Lichtenstein technique
  • will comply with required follow-up study visits
  • willing and able to provide written informed consent

Exclusion Criteria:

  • BMI ≥35
  • life expectancy of <3 years
  • strangulated hernia
  • urologic disorder and/or previous urologic surgery in the testicular area (with the exception of prostate surgery)
  • active abdominal surgical condition such as bowel obstruction or perforation
  • local or systemic infection or peritonitis
  • known disease that impairs wound healing
  • anti-platelet therapy (other than aspirin) for >7 days preceding the surgical procedure
  • previous ipsilateral groin incision
  • receiving immunosuppressive therapy and/or has undergone radiation therapy to the affected groin area
  • uncontrolled insulin-dependent diabetic with Hgb1Ac greater than 8
  • advanced cirrhosis with Child-Turcott Class of C or higher
  • severe COPD requiring home oxygen
  • diagnosed with chronic pain syndrome or is undergoing treatment for pain management
  • candidate for another major surgical procedure with the inguinal hernia repair
  • enrolled in another investigational study that may confound the results of this study
  • known drug abuser
  • on anti-psychotic medications
  • Worker's Compensation case

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Technical success with no complications through 6 weeks.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Hernia recurrence
Time Frame: 1 year
1 year
Pain and functional status
Time Frame: 10 day, 6 weeks, 6 months 1 year
10 day, 6 weeks, 6 months 1 year
Incidence of complications
Time Frame: 10 days, 6 weeks, 6 months, 1 year
10 days, 6 weeks, 6 months, 1 year

Collaborators and Investigators

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

Sponsor

Biomerix

Investigators

  • Principal Investigator: Samir S Awad, MD, Baylor College of Medicine

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

June 1, 2009

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 18, 2009

First Posted (Estimate)

June 19, 2009

Study Record Updates

Last Update Posted (Estimate)

October 4, 2010

Last Update Submitted That Met QC Criteria

October 1, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMX-2008-03

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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