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Completed

NCT Number: NCT06034652

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

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Key information

Conditions

Hernia HERNIA, VENTRAL Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Surgical Healing Arts

Fort Myers, Florida, 33912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With Clinically Confirmed Recurrence

    Time frame: Through study completion, an average of 4 months.

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

Secondary outcomes

  1. Self-Reported Recurrence

    Time frame: Through study completion, an average of 4 months.

    Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.

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

    Time frame: Through study completion, an average of 4 months.

    Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) of the primary hernia repair to date, including not previously reported in T-GENVIH-002.

  3. Number of Participants With Surgical Site Occurrences (SSOs)

    Time frame: Through study completion, an average of 4 months.

    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.

  4. Number of Subjects With Surgical Site Infections (SSIs)

    Time frame: Through study completion, an average of 4 months.

    Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not previously reported in T-GENVIH-002 study.

  5. Number of Participants With Self-Reported Recurrence

    Time frame: Through study completion, an average of 4 months.

    Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2023
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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