Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
NCT07070115 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 173
Last updated 2026-02-09
Summary
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
Conditions
- Hiatal Hernia
Interventions
- 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.
Sponsors & Collaborators
-
Tela Bio Inc
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-25
- Primary Completion
- 2031-12-31
- Completion
- 2032-07-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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