A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix
Tela Bio Inc
Summary
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
Description
This prospective, open-label, multicenter, non-randomized, post-market study will enroll up to 173 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.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient is a candidate for an elective robotic or laparoscopic primary hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable. 2. Patient is willing and able to voluntarily sign the IRB-approved Informed Consent Form for the study. 3. Patient is at least 22 years old at the time of surgery. 4. Patient is not pregnant and not planning to become pregnant during the duration of the study (5 years). 5. Patient is able and willing to comply with the study requirements including completion of patient questionnaires and clinic evaluations. Exclusi…
Interventions
- DeviceOviTex Reinforced Tissue Matrix
All study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists.
Locations (2)
- University of South Alabama HealthMobile, Alabama
- The University of Texas at Austin - Dell Medical SchoolAustin, Texas