Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT02408458
Eligibility Criteria:
Inclusion Criteria:
* between 18 and 80 years old on the day of study enrollment
* ventral or incisional hernia greater than 9 cm2 for which the physician anticipates ability to achieve midline fascia closure following a retro-rectus repair/component separation
* hernia classified as CDC class 1 or 2 preoperatively
* able and willing to sign the consent form and comply with all study visits and procedures
* commit to non-smoking for at least 4 weeks prior to procedure
Exclusion Criteria:
* sensitivity to porcine material
* scheduled for a concomitant procedure of a wound classified as other than clean
* immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the Investigator
* BMI ≥40
* A1C level ≥10.0
* participating in another clinical study
* cirrhosis, and/or ascites
* diagnosed with a collagen vascular disorder
* American Society of Anesthesiology (ASA) Class 4 or 5
* allergic to tetracycline or kanacmycin
* life expectancy of less than 2 years at the time of enrollment
* any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02408458
Study Brief:
Protocol Section:
NCT02408458