Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

Not Applicable

Recruiting

• Conditions: Hiatal Hernia

• Registration Number: NCT07070115
• Lead Sponsor: Tela Bio Inc

Brief Summary

This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-07-14
• Study First Posted: 2025-07-17
• Study Start: 2025-07-25
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-06
• Primary Completion: 2031-12-31
• Study Completion: 2032-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 133

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hernia recurrence	At 24 months	Incidence of radiographic recurrence at 24 months, defined as \> 2cm above the hiatus via barium swallow.

Secondary Outcome Measures

Name	Time	Method
Early post-operative complications	Occurring within the first 3 months of the hiatal hernia repair	Incidence of early post-operative device-related complications noted at the hernia repair site occurring ≤ 90 days after index hiatal hernia repair

Trial Locations

Locations (1)

The University of Texas at Austin - Dell Medical School; 🇺🇸 Austin, Texas, United States