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← Trials
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Ovitex in Paraesophageal and Large Hiatal Hernia Repair

RecruitingNAAges 18 Years - 85 YearsAllForegut Research Foundation
NCT06193551 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Ovitex LPR
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Where

1 site
Institute of Esophageal and Reflux Surgery
Lone Tree, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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