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

A Prospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair as Long Term Follow Up to T-GENVIH-002 Study

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.

Study Overview

• Status: Completed
• Conditions: Hernia; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia, Ventral
• Intervention / Treatment: Device: Integra® Gentrix® Surgical Matrix

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

• Study Contact: Name: Karen Bartku; Phone Number: 727.899.0990; Email: karen.bartku@integralife.com
• Study Contact Backup: Name: Andrew Tummon; Phone Number: 609.936.5490; Email: andrew.tummon@integralife.com

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Surgical Healing Arts
      • Contact: Alfredo Mier y Leon; Phone Number: 239-344-9876; Email: alfredo@surgicalhealingarts.com
      • Contact: Kelsey Vest; Phone Number: 239.344.9786

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Confirmed Recurrence	1. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.	1 year to present

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Recurrence	Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.	1 year to present
Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI)	Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) of the primary hernia repair to date, including not previously reported in T-GENVIH-002.	1 year to present
Incidence of Surgical Site Occurrences (SSOs)	Incidence of Surgical Site Occurrences (SSOs) of the primary hernia repair to date (seroma, abscess, dehiscence, hematoma, wound necrosis, ileus, fistula, delayed wound healing), including not previously reported in T-GENVIH-002 study.	1 year to present
Incidence of Surgical Site Infections (SSIs)	Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not previously reported in T-GENVIH-002 study.	1 year to present

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Director: Adam Young, PhD PMP, Integra LifeSciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Actual): January 19, 2024
• Study Completion (Actual): January 19, 2024

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hernia; Hernia, Ventral; Hernia, Abdominal; Internal Hernia; Pathological Conditions, Anatomical
• Other Study ID Numbers: T-GENVIH-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes