Actively Recruiting
Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
Led by Tela Bio Inc · Updated on 2026-02-09
173
Participants Needed
2
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
CONDITIONS
Official Title
Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Patient has a Body Mass Index (BMI) of 35 or higher.
- Patient meets the CDC Surgical Site Infection Wound Classification Class IV (Dirty-Infected) criteria.
- Patient has a Type I hiatal hernia (only the esophagogastric junction is above the diaphragm).
- Patient has a life expectancy of less than five years.
- 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 (e.g., LINX).
- Patient's surgery requires the use of an additional mesh device or a pledget for reinforcement.
- Patient has participated in another gastrointestinal 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 requiring emergent intervention.
- Patient is a prisoner.
- 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 (e.g., LINX).
- Surgery performed as an open procedure.
- Patient has a condition that may increase risk, confound study data, or interfere significantly with participation, as determined by the Investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of South Alabama Health
Mobile, Alabama, United States, 36617
Actively Recruiting
2
The University of Texas at Austin - Dell Medical School
Austin, Texas, United States, 78712
Actively Recruiting
Research Team
M
Melissa LaMantia, MA
CONTACT
D
Danielle Campbell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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