Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 18-85 year old with PEH and appropriate surgical indication for repair
Locations
United States
Colorado
Institute of Esophageal and Reflux Surgery
RECRUITING
Lone Tree
Contact Information
Primary
Kate Freeman, MSN
kate@iersurgery.com
3037887700
Time Frame
Start Date: 2024-02-19
Estimated Completion Date: 2030-06
Participants
Target number of participants: 100
Treatments
Other: Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair
This is a single arm, open label, nonrandomized study evaluating 100 subjects diagnosed with a paraesophageal or large hiatal hernia planning to undergo surgical repair with the study investigators.
Related Therapeutic Areas
Sponsors
Leads: Foregut Research Foundation