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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hernia
Hernia, Abdominal
Hernia, Ventral
Internal Hernia
Pathological Conditions, Anatomical

Clinical Trial Details

NCT number	NCT06034652
Study type	Observational
Source	Integra LifeSciences Corporation
Contact
Status	Completed
Phase
Start date	September 12, 2023
Completion date	January 19, 2024

View Details

See also
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