NCT06034652

T-GENVIH-003 LTFU (Long Term Follow Up) Study

A Prospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair as Long Term Follow Up to T-GENVIH-002 Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix® Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population (i.e., the twenty-one minimally invasive surgical approach cases) from the prior T-GENVIH-002 study.

Detailed description

The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs from a sub-population of twenty-one participants from the previous T-GENVIH-002 study, specifically those with laparoscopic or robotic repair. Prospective data will be collected via a one-off study follow-up visit and assessed for later post-operative surgical site events and complications in the post-operative period from the last timepoint of data collection in T-GENVIH-002 to present.

Conditions

• Hernia
• Hernia, Ventral
• Pathological Conditions, Anatomical
• Hernia, Abdominal

Interventions

Type	Name	Description
DEVICE	Integra® Gentrix® Surgical Matrix	Integra® Gentrix® Surgical Matrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic \& reconstructive surgery.

Timeline

• Start date: 2023-09-12
• Primary completion: 2024-01-19
• Completion: 2024-01-19
• First posted: 2023-09-13
• Last updated: 2025-05-20
• Results posted: 2025-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study