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Ovitex in Paraesophageal and Large Hiatal Hernia Repair
Recruiting
Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
Inclusion Criteria: * 18-85 year old with PEH and appropriate surgical indication for repair Exclusion Criteria: * Under 22 years of age. * In need of an emergency procedure. * Currently being treated with another investigational drug or device. * Have had prior gastric or esophageal surgery. * Have had any previous intervention for GERD. * Are suspected or confirmed to have esophageal or gastric cancer. * Have a Body Mass Index (BMI) greater than 45. * Cannot understand trial requirements or are unable to comply with follow-up schedule. * Are pregnant, nursing, or plan to become pregnant. * Have a mental health disorder that would interfere with your ability to follow study instructions. * Have suspected or known allergies to Ovitex * Have an illness that may cause you to be unable to meet the protocol requirements or is associated with shortened life expectancy.
About the study
The purpose of the study is to evaluate the success of hiatal hernia repairs in patients with large (\>5cm) or paraesophageal hernias when Ovitex LPR mesh used during the repair.
What is being tested
- Ovitex LPR (device)
Sponsor: Foregut Research Foundation · Participants: 100 · Started: Feb 19, 2024
Contact the study team
- Kate Freeman, MSN · Phone: 3037887700
Official record on ClinicalTrials.gov — NCT06193551
Locations in the U.S.
| Colorado | Institute of Esophageal and Reflux Surgery, Lone Tree |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.