Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

Launched by TELA BIO INC · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for hiatal hernia, which is a condition where part of the stomach pushes up through the diaphragm into the chest. The study will look at how well a special surgical material called OviTex (either Core Resorbable or 1S Resorbable) works to repair the hernia and prevent it from coming back, as well as any problems that might happen after surgery. The goal is to better understand the success and safety of using OviTex in hernia repairs.

People who might be eligible for this study are adults aged 22 or older who are scheduled to have a planned (not emergency) hiatal hernia repair using a minimally invasive robotic or laparoscopic surgery with OviTex. Participants should be able to give informed consent, agree to follow-up visits and questionnaires over five years, and must not be pregnant or planning pregnancy during the study. Some people will not qualify, such as those with very high body weight, certain types of hernias, previous hernia repairs, current nicotine use, or allergies to materials used in the surgery. If you join, you can expect to have the hernia repair surgery with OviTex and then follow the study’s check-ups to see how well the repair holds up and to monitor your recovery over time.

Gender

ALL

Eligibility criteria

• 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.
• Exclusion Criteria (Baseline):
• • 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.
• Exclusion Criteria (Intra-operative):
• • 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.