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Ovitex for Paraesophageal and Large Hiatal Hernia Repair

This study is looking at how well a surgical mesh called Ovitex LPR works for people having surgery for large hiatal hernias or paraesophageal hernias. These hernias happen when part of your stomach pushes up into your chest. During surgery, doctors will use Ovitex LPR mesh along with permanent stitches to reinforce the repair. The main goal is to see how many people have their hernia come back (recurrence) after 5 years. You might be able to join if you are between 18 and 85 years old and need surgery for one of these hernias. You cannot join if you've had previous stomach or esophagus surgery, or if you're in another experimental treatment.

Study design
This study is a single-site study involving about 100 participants, all receiving the Ovitex LPR mesh during their hernia repair.
What's involved
You will have pre-operative assessments, the surgery, and then follow-up visits at 1, 3, and 5 years after surgery, which will include questionnaires and barium swallow tests.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after their surgery to check for hernia recurrence.

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NCT06193551

Ovitex in Paraesophageal and Large Hiatal Hernia Repair

Recruiting
NAAges 18–85InterventionalTreatment
Foregut Research Foundation
~100 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:Ovitex LPR

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm
Measured over 5 years

Conditions

Paraesophageal Hernia
Large Hiatal Hernia

Explore related trials

Hiatal HerniaParaesophageal hernia

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Kate Freeman, MSN · STUDY_DIRECTOR · Foregut Research Foundation

Who to contact

Kate Freeman, MSN
[email protected]
3037887700
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm5 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