Evaluating OviTex for Hiatal Hernia Repair

This study is looking at how well a device called OviTex Reinforced Tissue Matrix works for people having surgery to fix a hiatal hernia. A hiatal hernia happens when part of your stomach pushes up through your diaphragm (the muscle that separates your chest and abdomen). All participants will receive OviTex during their robotic or laparoscopic hernia repair. The main goal is to see how often the hernia comes back after 24 months. You might be able to join if you are at least 22 years old and are a candidate for this type of hernia repair. The study is currently enrolling up to 173 people.

Study design
This is an open-label study, meaning both you and your doctors will know you are receiving OviTex. It is a multicenter study enrolling up to 173 participants.
What's involved
You will undergo a minimally invasive hiatal hernia repair using OviTex. You will have clinical follow-up appointments for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will have clinical follow-up for up to 5 years after their surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07070115

Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

Recruiting
NAAges 22+InterventionalTreatment
Tela Bio Inc
~173 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:OviTex Reinforced Tissue Matrix

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hernia recurrence
Measured over At 24 months
Hiatal Hernia
5 sites across 5 states
Alabama1
Colorado1
Kentucky1
North Carolina1
Texas1

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  • Hernia recurrenceAt 24 months

    Incidence of radiographic recurrence at 24 months, defined as \> 2cm above the hiatus via barium swallow.