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

Integra LifeSciences

Status: Completed

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

Treatments: Device: Integra® Gentrix® Surgical Matrix

Study type: Observational

Funder types: Industry

Identifiers

NCT06034652

T-GENVIH-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

8 participants in 1 patient group

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

Description:

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.

Treatment:

Device: Integra® Gentrix® Surgical Matrix