Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)
Foregut Research Foundation
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.
Description
This is an investigator initiated, single site, single arm study investigating the recurrence rate of hiatal hernia and safety using Ovitex LPR in patients undergoing hiatal hernia repair. Ovitex LPR mesh is a reinforced tissue matrix, comprised of a fine non-absorbable polymer suture interwoven through layers of absorbable biologic material in a "lockstitch" pattern.The biologic material in OviTex, derived from ovine rumen (sheep stomach), serves as the natural building block and is optimized to reduce foreign body response, enable functional tissue remodeling and promote a more natural hern…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
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.…
Interventions
- DeviceOvitex LPR
Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.
Location
- Institute of Esophageal and Reflux SurgeryLone Tree, Colorado