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Active Not Recruiting
NCT05610267
Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Conditions: Ventral Hernia
Sex: All
Ages: 22 Years – 80 Years
Enrollment: 29
Sponsor: Integra LifeSciences Corporation
Location: United States
Summary
The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs.
Eligibility Criteria
Inclusion Criteria: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)..Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix.Exclusion Criteria:Subject has known allergy to porcine-derived products.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.Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection.Subject had uncontrolled diabetes, defined as Hb1AC value >7% within 12 weeks prior to index procedure.Subject has been diagnosed with cirrhosis and/or ascites.
Source: ClinicalTrials.gov (NCT05610267). StuddyBuddy aggregates publicly available trial information.