Study of Surgical Mesh for Inguinal Hernia Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Biomerix.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Biomerix
ClinicalTrials.gov Identifier:
NCT00924755
First received: June 17, 2009
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Hernia, Inguinal
Device: Biomerix Revive™ (surgical mesh for inguinal hernia repair)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique

Resource links provided by NLM:


Further study details as provided by Biomerix:

Primary Outcome Measures:
  • Technical success with no complications through 6 weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hernia recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Pain and functional status [ Time Frame: 10 day, 6 weeks, 6 months 1 year ] [ Designated as safety issue: No ]
  • Incidence of complications [ Time Frame: 10 days, 6 weeks, 6 months, 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: June 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Biomerix Revive™ (surgical mesh for inguinal hernia repair)
    Inguinal hernia repair using a tension-free onlay patch, Lichtenstein-style.
    Other Name: Revive
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924755

Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68178
United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biomerix
Investigators
Principal Investigator: Samir S Awad, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Christina Kichula, Biomerix
ClinicalTrials.gov Identifier: NCT00924755     History of Changes
Other Study ID Numbers: BMX-2008-03
Study First Received: June 17, 2009
Last Updated: October 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Biomerix:
Surgical mesh

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on September 14, 2014