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

NCT ID: NCT06034652

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-12
• Study Completion Date: 2024-01-19

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 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective Analysis of Minimally Invasive Surgical Approach (i.e., laparoscopic or robotic)

Collection of performance data for twenty-one subjects having prior minimally invasive surgical approach for ventral hernia repair (i.e., laparoscopic or robotic) from the previous T-GENVIH-002 study last data collection time-point (1-yr post-op) to present (prospective analysis), not previously reported.

Integra® Gentrix® Surgical Matrix

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• Not applicable.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Young, PhD PMP

Role: STUDY_DIRECTOR

Integra LifeSciences Corporation

Locations

Surgical Healing Arts

Fort Myers, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

T-GENVIH-003

Identifier Type: -

Identifier Source: org_study_id