Ovitex in Paraesophageal and Large Hiatal Hernia Repair (NCT06193551) | Clinical Trial Compass
RecruitingNot Applicable
Ovitex in Paraesophageal and Large Hiatal Hernia Repair
United States100 participantsStarted 2024-02-19
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm