- Trial ID:
- Mark Takata
Inclusion Criteria: - Subject suffers from an uncomplicated ventral hernia that requires surgical repair (open, laparoscopic, or robotic) with the use of an implant to reinforce or replace weakened or missing tissue. - The size of the implant needed for repair is expected to be 18 x 22 cm, 20 x 20 cm or less. - Subject meets CDC/SSI Wound Classification Class I (Clean) or Class II (Clean-Contaminated) criteria - Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study. - Subject is able to complete Quality of Life (QoL) and pain Questionnaires. - Subject is at least 18 years old (or considered an adult per state law). - Subject is able to participate fully in, and for the full duration of, the study. Exclusion Criteria: - Subject has a BMI of > 40. - Subject meets CDC/SSI Wound Classification Class IV(Dirty-Infected) criteria. - Subject is female and is pregnant. - Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up. - Subject has recent history of drug or alcohol abuse (in last 3 years). - Subject has an allergy to ovine-derived products. - Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial. - Subject is unable to receive OviTex® Permanent 1S reinforced bioscaffold at the time of surgery. Intra-operative Exclusion Criteria - Subject requires implant that exceeds 18 x 22 cm or 20 x 20 cm. - Subject unable to receive OviTex® Permanent 1S reinforced bioscaffold at time of surgery.
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
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