Actively Recruiting
Ovitex in Paraesophageal and Large Hiatal Hernia Repair
Led by Foregut Research Foundation · Updated on 2026-02-09
100
Participants Needed
1
Research Sites
327 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ovitex in Paraesophageal and Large Hiatal Hernia Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 85 years old with paraesophageal hernia and appropriate surgical indication for repair
You will not qualify if you...
- Under 22 years of age
- Need for an emergency procedure
- Currently treated with another investigational drug or device
- Prior gastric or esophageal surgery
- Previous intervention for gastroesophageal reflux disease
- Suspected or confirmed esophageal or gastric cancer
- Body Mass Index greater than 45
- Inability to understand trial requirements or comply with follow-up
- Pregnant, nursing, or planning pregnancy
- Mental health disorder interfering with study participation
- Suspected or known allergies to Ovitex
- Illness causing inability to meet protocol or shortened life expectancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Esophageal and Reflux Surgery
Lone Tree, Colorado, United States, 80124
Actively Recruiting
Research Team
K
Kate Freeman, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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