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

NCT06034652 | Completed Results FDA Device

• 1 other identifier: T-GENVIH-003
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia; Hernia, Ventral; Pathological Conditions, Anatomical; Hernia, Abdominal

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Confirmed Recurrence

  1\. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.

  Through study completion, an average of 4 months.

Secondary Outcomes (5)

• Self-Reported Recurrence

  Through study completion, an average of 4 months.

• Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI)

  Through study completion, an average of 4 months.

• Number of Participants With Surgical Site Occurrences (SSOs)

  Through study completion, an average of 4 months.

• Number of Subjects With Surgical Site Infections (SSIs)

  Through study completion, an average of 4 months.

• Number of Participants With Self-Reported Recurrence

  Through study completion, an average of 4 months.

Study Arms (1)

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.

Device: Integra® Gentrix® Surgical Matrix

Interventions

Integra® Gentrix® Surgical Matrix DEVICE

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

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

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects from the sub-population of minimally invasive surgical approach (e.g., laparoscopic or robotic) ventral hernia repair of the prior T-GENVIH-002 study.

You may qualify if:

• 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.

You may not qualify if:

• Not applicable.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (1)

Surgical Healing Arts

Fort Myers, Florida, 33912, United States

Location

MeSH Terms

Conditions

Hernia; Hernia, Ventral; Pathological Conditions, Anatomical; Hernia, Abdominal

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Andrew Tummon, Director, Global Clinical Operations
• Organization: Integra LifeSciences Corporation

andrew.tummon@integralife.com

609-936-5490

Study Officials

• Adam Young, PhD PMP

  Integra LifeSciences Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: September 12, 2023
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)