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Study of Surgical Mesh for Inguinal Hernia Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Biomerix.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00924755
First Posted: June 19, 2009
Last Update Posted: October 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biomerix
  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: Intervention Model: Single Group Assignment
Masking: None (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:

MedlinePlus related topics: Caffeine Hernia
U.S. FDA Resources

Further study details as provided by Biomerix:

Primary Outcome Measures:
  • Technical success with no complications through 6 weeks. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Hernia recurrence [ Time Frame: 1 year ]
  • Pain and functional status [ Time Frame: 10 day, 6 weeks, 6 months 1 year ]
  • Incidence of complications [ Time Frame: 10 days, 6 weeks, 6 months, 1 year ]
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Christina Kichula, Biomerix
ClinicalTrials.gov Identifier: NCT00924755     History of Changes
Other Study ID Numbers: BMX-2008-03
First Submitted: June 17, 2009
First Posted: June 19, 2009
Last Update Posted: October 4, 2010
Last Verified: October 2010

Keywords provided by Biomerix:
Surgical mesh

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
 Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents


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