NCT04779918

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Tela Bio Inc · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is intended to evaluate the post-operative complications and recurrence following the use of OviTex in ventral or inguinal hernias being treated robotically. It is a single-arm study and all subjects will receive OviTex.

Conditions

• Hernia, Ventral
• Hernia, Inguinal

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: 2021-04-29
• Primary completion: 2026-03-30
• Completion: 2027-12-30
• First posted: 2021-03-03
• Last updated: 2025-10-10

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study