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RecruitingNot ApplicableNCT06193551

Ovitex in Paraesophageal and Large Hiatal Hernia Repair

Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)

Sponsor

Foregut Research Foundation

Enrollment

100 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Paraesophageal HerniaLarge Hiatal Hernia

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria1

  • year old with PEH and appropriate surgical indication for repair

Exclusion Criteria12

  • 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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Interventions

DEVICEOvitex LPR

Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.

Locations(1)

Institute of Esophageal and Reflux Surgery

Lone Tree, Colorado, United States

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NCT06193551

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