NCT07070115

Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 173 (estimated)
• Sponsor: Tela Bio Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This prospective, open-label, multicenter, non-randomized, post-market study will enroll up to 173 subjects in the United States. Patients undergoing an elective hiatal hernia repair and who meet all eligibility criteria will be enrolled in the study. Subjects will undergo minimally invasive procedures for hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable for reinforcement. Subjects will have clinical follow-up through 5 years. Data collected in this study will be compared to a literature control at 24 months.

Conditions

• Hiatal Hernia

Interventions

Type	Name	Description
DEVICE	OviTex 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.

Timeline

• Start date: 2025-07-25
• Primary completion: 2031-12-31
• Completion: 2032-07-31
• First posted: 2025-07-17
• Last updated: 2026-02-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study