RecruitingNot Applicable

Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

United States173 participantsStarted 2025-07-25

Plain-language summary

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

Who can participate

Age range22 Years

SexALL

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Inclusion criteria

✓. 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

✕. 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.

What they're measuring

Hernia recurrence

Timeframe: At 24 months

Trial details

NCT IDNCT07070115

SponsorTela Bio Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-12-31

Contact for this trial

Melissa LaMantia, MA

757-761-4922 mlamantia@telabio.com

View on ClinicalTrials.gov More Hiatal Hernia trials