Status:
RECRUITING
Ovitex in Paraesophageal and Large Hiatal Hernia Repair
Lead Sponsor:
Foregut Research Foundation
Conditions:
Paraesophageal Hernia
Large Hiatal Hernia
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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.
Detailed Description
This is an investigator initiated, single site, single arm study investigating the recurrence rate of hiatal hernia and safety using Ovitex LPR in patients undergoing hiatal hernia repair. Ovitex LPR...
Eligibility Criteria
Inclusion
- 18-85 year old with PEH and appropriate surgical indication for repair
Exclusion
- 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.
Key Trial Info
Start Date :
February 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06193551
Start Date
February 19 2024
End Date
June 1 2030
Last Update
June 13 2024
Active Locations (1)
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1
Institute of Esophageal and Reflux Surgery
Lone Tree, Colorado, United States, 80124