Study of Surgical Mesh for Inguinal Hernia Repair
Status unconfirmed · Phase 4
Conditions studied: Hernia, Inguinal
In brief
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.
Key facts
- Study ID
- NCT00924755
- Run by
- Biomerix
- People needed
- 25
- Starts
- 2009-06-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2010-10-04
Who can join
Age: 19 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Creighton University — Omaha, Nebraska, United States
- Michael E. DeBakey Veterans Affairs Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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