Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
NCT04779918 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2026-05-05
Summary
This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.
Conditions
- Hernia, Ventral
- Hernia, Inguinal
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
-
MCRA
collaborator INDUSTRY -
Tela Bio Inc
lead INDUSTRY
Principal Investigators
-
Geoffrey Slayden, MD · St. Lukes Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-04-29
- Primary Completion
- 2027-03-30
- Completion
- 2029-12-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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