Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

Eligibility 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.
• 1. Patient has a Body Mass Index (BMI) of ≥ 35.
• 2. Patient meets the Centers for Disease Control (CDC) Surgical Site Infection (SSI) Wound Classification Class IV (Dirty-Infected) criteria.
• 3. Patient has a Type I hiatal hernia.
• 4. Patient has a life expectancy of less than five years making it unlikely that the subject will successfully achieve five-year follow-up.
• 5. Patient is a current nicotine user (including smokeless, vaporized, etc.)
• 6. Patient has a history of illicit drug or alcohol abuse (in the last three years).
• 7. Patient has an allergy to ovine-derived products or a known sensitivity to polyglycolic acid (PGA).
• 8. Patient has an allergy to barium.
• 9. Patient's surgery will include the use of an anti-reflux implantable device (LINX, etc.).
• 10. Patient's surgery requires the use of an additional mesh device or a pledget for reinforcement.
• 11. Patient has participated in another gastrointestinal (GI) clinical study within the past 30 days or is currently involved in another clinical study excluding observational and registry studies.
• 12. Patient had previous surgery at the gastroesophageal junction.
• 13. Patient had a prior hiatal hernia repair.
• 14. Patient has an incarcerated hernia that requires emergent intervention.
• 15. Patient is a prisoner.
• 1. Patient is unable to receive OviTex Core Resorbable or OviTex 1S Resorbable at time of surgery.
• 2. Surgery requires the use of an additional mesh device or a pledget for reinforcement.
• 3. Surgery includes the use of an anti-reflux implantable device (LINX, etc.).
• 4. Surgery performed as an open procedure.
• 5. Patient has a condition, which in the Investigator's opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient's participation in the study.