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

Hernia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06034652
• Other study ID #: T-GENVIH-003
• Status: Completed
• Start date: September 12, 2023
• Est. completion date: January 19, 2024

Study information

• Verified date: January 2024
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 19, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal
• Hernia, Ventral
• Internal Hernia
• Pathological Conditions, Anatomical

Intervention

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.

Locations

Country	Name	City	State
United States	Surgical Healing Arts	Fort Myers	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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