Digestive Health Clinical Trials
A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix
Learn moreWhat is the purpose of this study?
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
Eligibility
- 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.
(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.).
- Surgery performed as an open procedure.
- 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 can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix
- Disease Type/ConditionHiatal HErnia
- Principal InvestigatorChristy M. Dunst, MD
- Co-InvestigatorsMelissa DeSouza, MD, Katherine Blevin, MD, Adrian Dobroswolsky, MD
- Age GroupAdult, Older Adult
- PhaseN/A
- ClinicalTrials.gov IDNCT07070115
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
Hoag Digestive Health Institute
Hoag Digestive Health Institute provides advanced, comprehensive care for the full spectrum of digestive conditions, with access to world-class specialists, diagnostics and imaging, advanced interventional therapeutics, and clinical trials. Patients benefit from a research-driven approach that connects leading-edge treatment options with personalized care across gastroenterology and GI surgery.
