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Ovitex in Paraesophageal and Large Hiatal Hernia Repair — OviPHeR  

Paraesophageal Hernia Clinical Trial

Official title:
Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)

Clinical Trial 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.

Clinical Trial 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 hernia repair. The interwoven polymer fibers provide additional reinforcement, along with improved handling and load-sharing capability. The permanent polymer fiber (polypropylene) is a standard surgical suture material that is used in hiatal hernia surgery and comprises less than 5% of the final product. Preop details, quality of life questionnaires and surgery details will be collected along with post op GERD (gastro esophageal reflux disease) quality of life questionnaires and barium swallow esophagrams to objectively examine recurrence of hiatal hernia at 1, 3, and 5 years post op. Data will be carefully collected and reviewed for discrepancies and verified with source prior to analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06193551
Study type Interventional
Source Foregut Research Foundation
Contact Kate Freeman, MSN
Phone 3037887700
Email kate@iersurgery.com
Status Recruiting
Phase N/A
Start date February 19, 2024
Completion date June 2030
View Details
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