Status:
COMPLETED
T-GENVIH-003 LTFU (Long Term Follow Up) Study
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Hernia
Hernia, Ventral
Eligibility:
All Genders
22-80 years
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- Patient was a subject in the T-GENVIH-002 study and underwent minimally invasive (i.e., laparoscopic or robotic) abdominal wall reconstruction for a primary hernia using Integra® Gentrix® Surgical Matrix.
- Subject has participated in the informed consent process and signed a study-specific informed consent document.
- Subject is fluent in US English or US Spanish language.
- Subject is willing to complete an e-consent and phone or in-office visit.
Exclusion
- Not applicable.
Key Trial Info
Start Date :
September 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 19 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06034652
Start Date
September 12 2023
End Date
January 19 2024
Last Update
May 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Surgical Healing Arts
Fort Myers, Florida, United States, 33912