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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT05610267
Eligibility Criteria:
Inclusion Criteria:
1. Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection)..
2. Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix.
Exclusion Criteria:
1. Subject has known allergy to porcine-derived products.
2. Subject required use of Gentrix® device and a second non-Gentrix surgical mesh in the same plane or in different planes for single hernia e.g., Gentrix sublay and a synthetic device in the onlay position.
3. Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection.
4. Subject had uncontrolled diabetes, defined as Hb1AC value \>7% within 12 weeks prior to index procedure.
5. Subject has been diagnosed with cirrhosis and/or ascites.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
80 Years
Study:
NCT05610267
Study Brief:
Protocol Section:
NCT05610267