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

NCT06034652 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2025-05-20

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Adam Young, PhD PMP · Integra LifeSciences Corporation

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2024-01-19
Completion
2024-01-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06034652 on ClinicalTrials.gov