RecruitingNot ApplicableNCT07070115

Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix

Sponsor

Tela Bio Inc

Enrollment

173 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

Hiatal Hernia

Summary

This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called OviTex Reinforced Tissue Matrix for people with hiatal hernia. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOviTex Reinforced Tissue Matrix

All study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists.