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

• 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

• 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 outcomes

• 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.

Sex: All, ages: 22 Years to 80 Years

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.

Participant flow

Outcome results

• Number of Participants With Clinically Confirmed Recurrence (Primary), Count of participants, Participants: Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) 2
• Self-Reported Recurrence (Secondary), Count of participants, Participants: Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) 3
• Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI) (Secondary), Count of participants, Participants: Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) 1
• Number of Participants With Surgical Site Occurrences (SSOs) (Secondary), Count of participants, Participants: Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) 1
• Number of Subjects With Surgical Site Infections (SSIs) (Secondary), Count of participants, Participants: Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) 1
• Number of Participants With Self-Reported Recurrence (Secondary), Count of participants, Participants: Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) 8

Adverse events

Time frame: The safety objective is to capture existing Gentrix® Surgical Matrix Complication data in the longer term period post primary repair procedure -- to date (i.e., through study completion, an average of 4 months) -- not previously reported in T-GENVIH-002 study.

• Study Protocol (PDF, 2023-08-02)
• Statistical Analysis Plan (PDF, 2023-09-18)

• Adam Young, PhD PMP, Study director, Integra LifeSciences Corporation