Ovitex in Paraesophageal and Large Hiatal Hernia Repair

Description

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.

Conditions

Paraesophageal Hernia, Large Hiatal Hernia

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Study Overview

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Study Details

Study overview

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.

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

Ovitex in Paraesophageal and Large Hiatal Hernia Repair

Condition
Paraesophageal Hernia
Intervention / Treatment

-

Contacts and Locations

Lone Tree

Institute of Esophageal and Reflux Surgery, Lone Tree, Colorado, United States, 80124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Foregut Research Foundation,

Kate Freeman, MSN, STUDY_DIRECTOR, Foregut Research Foundation

Study Record Dates

2030-06