Ovitex in Paraesophageal and Large Hiatal Hernia Repair

Recruiting now · Not applicable

Conditions studied: Paraesophageal Hernia, Large Hiatal Hernia

In brief

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.

Key facts

Study ID

NCT06193551

Run by

Foregut Research Foundation

People needed

100

Starts

2024-02-19

Expected to finish

2030-06-01

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-85 year old with PEH and appropriate surgical indication for repair

You may not qualify if…

• 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.

Where it is running

• Institute of Esophageal and Reflux Surgery — Lone Tree, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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