Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
Description
This prospective, open-label, multicenter, non-randomized, post-market study will enroll up to 133 subjects in the United States. Patients undergoing an elective hiatal hernia repair and who meet all eligibility criteria will be enrolled in the study. Subjects will undergo minimally invasive procedures for hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable for reinforcement. Subjects will have clinical follow-up through 5 years. Data collected in this study will be compared to a literature control at 24 months.
Our expert team has 10+ years running successful recruitment campaigns for clinical research sites