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

Completed

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

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.

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Prospective Analysis of Minimally Invasive Surgical Approach (i.e., laparoscopic or robotic)	Integra® Gentrix® Surgical Matrix	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Confirmed Recurrence	Through study completion, an average of 4 months.	1. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.

Secondary Outcome Measures

Name	Time	Method
Self-Reported Recurrence	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.
Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI)	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.
Number of Participants With Surgical Site Occurrences (SSOs)	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.
Number of Subjects With Surgical Site Infections (SSIs)	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.
Number of Participants With Self-Reported Recurrence	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.