Study of Surgical Mesh for Inguinal Hernia Repair
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ClinicalTrials.gov Identifier: NCT00924755 |
Recruitment Status
: Unknown
Verified October 2010 by Biomerix.
Recruitment status was: Active, not recruiting
First Posted
: June 19, 2009
Last Update Posted
: October 4, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hernia, Inguinal | Device: Biomerix Revive™ (surgical mesh for inguinal hernia repair) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
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 |
Study Start Date : | June 2009 |
Estimated Primary Completion Date : | October 2010 |
Estimated Study Completion Date : | November 2010 |
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Device: Biomerix Revive™ (surgical mesh for inguinal hernia repair)
- Technical success with no complications through 6 weeks. [ Time Frame: 6 weeks ]
- 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 ]

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Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Samir S Awad, MD | Baylor College of Medicine |
Responsible Party: | Christina Kichula, Biomerix |
ClinicalTrials.gov Identifier: | NCT00924755 History of Changes |
Other Study ID Numbers: |
BMX-2008-03 |
First Posted: | June 19, 2009 Key Record Dates |
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 |