NCT06193551 · Foregut Research Foundation
Ovitex in Paraesophageal and Large Hiatal Hernia Repair
(OviPHeR)
What this study 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18-85 year old with PEH and appropriate surgical indication for repair
Exclusion criteria
- 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.
Where
- Lone Tree, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 9, 2026 · Source of record for eligibility and locations