Repairing large hiatal hernias using Ovitex mesh
Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)
This study is testing if a special mesh can help fix large hiatal hernias and see if it keeps them from coming back while also checking how safe it is for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Foregut Research Foundation Academic / other |
| Locations | 1 site (Lone Tree, Colorado) |
| Trial ID | NCT06193551 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Ovitex LPR mesh in repairing large paraesophageal and hiatal hernias. It is a single-site, single-arm investigation focusing on the recurrence rates of hernias and the safety of the mesh. The Ovitex mesh, made from a combination of non-absorbable polymer and absorbable biologic material, aims to enhance tissue remodeling and reduce foreign body response. Data will be collected preoperatively and postoperatively, including quality of life assessments and imaging studies to monitor hernia recurrence over a five-year period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with large or paraesophageal hernias requiring surgical repair.
Not a fit: Patients with a BMI over 45, prior gastric or esophageal surgeries, or those with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to lower recurrence rates of hiatal hernias and improved patient outcomes.
How similar studies have performed: While the use of biologic materials in hernia repair is established, the specific application of Ovitex LPR mesh in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lone Tree, Colorado
- Institute of Esophageal and Reflux Surgery — Lone Tree, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Kate Freeman, MSN
- Email: kate@iersurgery.com
- Phone: 3037887700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.