Ovitex in Paraesophageal and Large Hiatal Hernia Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-19

Study Completion Date

2030-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Paraesophageal Hernia Large Hiatal Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Clinical trial with a single arm of patients undergoing elective repair of paraesphageal hiatal hernia repair or large hiatal henia repair with implant of Ovitex-LPR.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Ovitex LPR

Intervention Type DEVICE

Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.

Interventions

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Ovitex LPR

Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No