N/A
N=8
T-GENVIH-003 LTFU (Long Term Follow Up) Study
Hernia · Hernia, Ventral · Pathological Conditions, Anatomical · Hernia, Abdominal
Bottom Line
View on ClinicalTrials.gov: NCT06034652 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Number of Participants With Clinically Confirmed Recurrence — 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Integra® Gentrix® Surgical Matrix (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Confirmed Recurrence |
2 | — |
| SECONDARY Self-Reported Recurrence |
3 | — |
| SECONDARY Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI) |
1 | — |
| SECONDARY Number of Participants With Surgical Site Occurrences (SSOs) |
1 | — |
| SECONDARY Number of Subjects With Surgical Site Infections (SSIs) |
1 | — |
| SECONDARY Number of Participants With Self-Reported Recurrence |
8 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06034652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.