Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
25 participants
INTERVENTIONAL
2009-06-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Biomerix Revive™ (surgical mesh for inguinal hernia repair)
Inguinal hernia repair using a tension-free onlay patch, Lichtenstein-style.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
MALE
No
Sponsors
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Biomerix
INDUSTRY
Responsible Party
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Biomerix
Principal Investigators
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Samir S Awad, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Creighton University
Omaha, Nebraska, United States
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States
Countries
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Other Identifiers
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BMX-2008-03
Identifier Type: -
Identifier Source: org_study_id