Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

Recruiting now · Not applicable

Conditions studied: Hiatal Hernia

In brief

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

Key facts

Study ID

NCT07070115

Run by

Tela Bio Inc

People needed

173

Starts

2025-07-25

Expected to finish

2032-07-31

Last updated by the study team

2026-02-09

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patient is willing and able to voluntarily sign the IRB-approved Informed Consent Form for the study.
• Patient is at least 22 years old at the time of surgery.
• Patient is not pregnant and not planning to become pregnant during the duration of the study (5 years).
• Patient is able and willing to comply with the study requirements including completion of patient questionnaires and clinic evaluations.
• Exclusion Criteria (Baseline):
• Patient has a Body Mass Index (BMI) of ≥ 35.
• Patient meets the Centers for Disease Control (CDC) Surgical Site Infection (SSI) Wound Classification Class IV (Dirty-Infected) criteria.
• Patient has a Type I hiatal hernia (defined as only the esophagogastric junction is above the diaphragm).
• Patient has a life expectancy of less than five years making it unlikely that the subject will successfully achieve five-year follow-up.
• Patient is a current nicotine user (including smokeless, vaporized, etc.)
• Patient has a history of illicit drug or alcohol abuse (in the last three years).
• Patient has an allergy to ovine-derived products or a known sensitivity to polyglycolic acid (PGA).
• Patient has an allergy to barium.
• Patient's surgery will include the use of an anti-reflux implantable device (LINX, etc.).
• Patient's surgery requires the use of an additional mesh device or a pledget for reinforcement.
• 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.
• Patient had previous surgery at the gastroesophageal junction.
• Patient had a prior hiatal hernia repair.
• Patient has an incarcerated hernia that requires emergent intervention.
• Patient is a prisoner.
• Exclusion Criteria (Intra-operative):
• Patient is unable to receive OviTex Core Resorbable or OviTex 1S Resorbable at time of surgery.
• Surgery requires the use of an additional mesh device or a pledget for reinforcement.
• Surgery includes the use of an anti-reflux implantable device (LINX, etc.).

Where it is running

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

Full record on ClinicalTrials.gov

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