Actively Recruiting
Ovitex in Paraesophageal and Large Hiatal Hernia Repair (OviPHeR)
Led by Foregut Research Foundation · Updated on 2026-02-09
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the success of hiatal hernia repairs in patients with large (over 5 cm) or paraesophageal hernias using the Ovitex LPR mesh. This single-site, investigator-initiated study focuses on the recurrence rate of hiatal hernias and the safety of repairs performed with this specific mesh. The study aims to gather detailed data on surgical outcomes, quality of life, and potential complications over time. The study involves a single group of 100 patients diagnosed with paraesophageal or large hiatal hernias who will undergo robotic-assisted laparoscopic surgery using permanent sutures reinforced with Ovitex LPR mesh. This mesh is made from a blend of biologic material derived from sheep stomach tissue combined with a small amount of permanent polymer fibers to support tissue remodeling and reduce foreign body response. The repair is reinforced with this mesh during surgery. Participants will provide preoperative information and complete quality of life questionnaires before and after surgery. They will undergo barium swallow esophagrams at 1, 3, and 5 years post-operation to check for hernia recurrence. The study will carefully review and verify all collected data. Researchers will measure the rate of hernia recurrence and monitor for mesh-related complications such as erosions over a five-year period.
CONDITIONS
Brief Title
Ovitex in Paraesophageal and Large Hiatal Hernia Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Diagnosed with paraesophageal or large hiatal hernia
- Appropriate surgical indication for hernia repair
You will not qualify if you...
- Under 22 years of age
- Require emergency surgery
- Currently treated with another investigational drug or device
- Prior gastric or esophageal surgery
- Previous intervention for gastroesophageal reflux disease (GERD)
- Suspected or confirmed esophageal or gastric cancer
- Body Mass Index (BMI) over 45
- Unable to understand trial requirements or comply with follow-up
- Pregnant, nursing, or planning pregnancy
- Mental health disorder interfering with study participation
- Known or suspected allergies to Ovitex
- Illness limiting ability to meet protocol or shortening life expectancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and immediate recovery period
Participants undergo robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.
1 surgery visit and immediate post-operative care
Duration - Up to 5 years post surgery
Participants complete quality of life questionnaires and undergo barium swallow esophagrams to assess recurrence of hiatal hernia and monitor for treatment related complications.
Visits at 1 year, 3 years, and 5 years post surgery
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
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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