Ovitex in Paraesophageal and Large Hiatal Hernia Repair (OviPHeR)

Foregut Research Foundation

Status

Enrolling

Conditions

Large Hiatal Hernia

Paraesophageal Hernia

Treatments

Device: Ovitex LPR

Study type

Interventional

Funder types

Other

Identifiers

NCT06193551

TelaBio

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair

Other group

Description:

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.

Treatment:

Device: Ovitex LPR