Hiatal hernia repair using OviTex reinforced tissue matrix

A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix

This will test whether using OviTex reinforced tissue matrix during minimally invasive hiatal hernia repair reduces recurrence and post-operative complications in adults having elective robotic or laparoscopic repair.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 173 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Tela Bio Inc (Industry-sponsored)
• Locations: 2 sites (Mobile, Alabama and 1 other locations)
• Trial ID: NCT07070115 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label, multicenter, non-randomized post-market study enrolling up to 173 adults in the United States. Eligible patients undergoing elective robotic or laparoscopic primary hiatal hernia repair will receive reinforcement with OviTex Core Resorbable or OviTex 1S Resorbable. Subjects will be followed clinically with patient questionnaires and clinic visits through five years, and outcomes at 24 months will be compared to a literature control. The study will track hernia recurrence and post-operative complications after minimally invasive repair with OviTex reinforcement.

Who should consider this trial

Good fit: Adults aged 22 or older who are candidates for elective robotic or laparoscopic primary hiatal hernia repair, can give informed consent, are not pregnant, and can comply with five years of follow-up are ideal candidates.

Not a fit: Patients with BMI ≥35, Type I hiatal hernia, dirty-infected surgical wounds (CDC Class IV), life expectancy under five years, or those not suitable for minimally invasive repair are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, using OviTex could lower hiatal hernia recurrence and reduce post-operative complications after minimally invasive repair.

How similar studies have performed: Prior studies of mesh and biologic reinforcement for hiatal hernia repair have produced mixed results, so this post-market evaluation of OviTex builds on existing but not definitive evidence.

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 (defined as only the esophagogastric junction is above the diaphragm).
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.

Where this trial is running

Mobile, Alabama and 1 other locations

• University of South Alabama Health — Mobile, Alabama, United States (Recruiting)
• The University of Texas at Austin - Dell Medical School — Austin, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Melissa LaMantia, MA

Conditions Hiatal Hernia; hiatal; hernia; reinforced tissue matrix