Ovitex in Paraesophageal and Large Hiatal Hernia Repair

Last updated: June 11, 2024
Sponsor: Foregut Research Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

Ovitex LPR

Clinical Study ID

NCT06193551
TelaBio
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-85 year old with PEH and appropriate surgical indication for repair

Exclusion

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-upschedule.

  • Are pregnant, nursing, or plan to become pregnant.

  • Have a mental health disorder that would interfere with your ability to follow studyinstructions.

  • Have suspected or known allergies to Ovitex

  • Have an illness that may cause you to be unable to meet the protocol requirements oris associated with shortened life expectancy.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Ovitex LPR
Phase:
Study Start date:
February 19, 2024
Estimated Completion Date:
June 30, 2030

Study 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.

Connect with a study center

  • Institute of Esophageal and Reflux Surgery

    Lone Tree, Colorado 80124
    United States

    Active - Recruiting

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