Ovitex in Paraesophageal and Large Hiatal Hernia Repair (OviPHeR)

February 5, 2026 updated by: Foregut Research Foundation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Institute of Esophageal and Reflux Surgery
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philip Woodworth, M.D.
        • Sub-Investigator:
          • Reginald Bell, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair
This is a single arm, open label, nonrandomized study evaluating 100 subjects diagnosed with a paraesophageal or large hiatal hernia planning to undergo surgical repair with the study investigators.
Device: Ovitex LPR
Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm
Time Frame: 5 years
Assess recurrence rates by objective measures when Ovitex LPR permanent polypropylene polymer reinforcement (Ovitex LPR) is placed during robotic-assisted repair of paraesophageal and large (> 5cm) hiatal hernias (henceforth PEH) using recurrence rate measurements defined as > 2cm axial hernia by Barium Swallow or endoscopy, if available
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment related mesh erosions as assessed by study quality of life questionnaire leading to endoscopy
Time Frame: 5 years
Assess the safety of using polypropylene support related to potential erosion as assessed by presence of symptoms using study quality of life questionnaire leading to endoscopy demonstrating mesh erosion
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foregut Research Foundation

Investigators

  • Study Director: Kate Freeman, MSN, Foregut Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2024

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TelaBio

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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