An observational study in Hernia, Hernia, Ventral and Pathological Conditions, Anatomical, sponsored by Integra LifeSciences Corporation. Completed at 1 site in United States. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Integra LifeSciences Corporation · Observational
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.
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's enrollment of 8 is below the median of 132 across 65 observational studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Integra LifeSciences Corporation is the lead sponsor of 82 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Compared within Hernia, Ventral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hernia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Subjects from the sub-population of minimally invasive surgical approach (e.g., laparoscopic or robotic) ventral hernia repair of the prior T-GENVIH-002 study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Number of Participants With Clinically Confirmed Recurrence
1. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
Time frame: Through study completion, an average of 4 months.
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.
Time frame: Through study completion, an average of 4 months.
Number of Participants With 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.
Time frame: Through study completion, an average of 4 months.
Number of Participants With 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.
Time frame: Through study completion, an average of 4 months.
Number of Subjects With 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.
Time frame: Through study completion, an average of 4 months.
Number of Participants With 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.
Time frame: Through study completion, an average of 4 months.
Subjects included in the study were from the sub-population of Minimally Invasive Surgical Approach (e.g., laparoscopic or robotic) of the T-GENVIH-002 study. No active recruitment was required.
| Milestone | Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) From GENVIH-002 Study. |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
1. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
| Participants | Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) |
|---|---|
| Number of Participants With Clinically Confirmed Recurrence | 2 |
Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
| Participants | Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) |
|---|---|
| Self-Reported Recurrence | 3 |
Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) of the primary hernia repair to date, including not previously reported in T-GENVIH-002.
| Participants | Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) |
|---|---|
| Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI) | 1 |
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.
| Participants | Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) |
|---|---|
| Number of Participants With Surgical Site Occurrences (SSOs) | 1 |
Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not previously reported in T-GENVIH-002 study.
| Participants | Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) |
|---|---|
| Number of Subjects With Surgical Site Infections (SSIs) | 1 |
Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
| Participants | Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) |
|---|---|
| Number of Participants With Self-Reported Recurrence | 8 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
Statistical Analysis will be based on data from all evaluable subjects meeting the eligibility criteria.
| Age, Continuous(Years) | Sub-population of Minimally Invasive Surgical Approach of the T-GENVIH-002 Study. |
|---|---|
| Median | 66.0 ± 13.47 |
| Sex: Female, Male(Participants) | Sub-population of Minimally Invasive Surgical Approach of the T-GENVIH-002 Study. |
|---|---|
| Female | 2 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Sub-population of Minimally Invasive Surgical Approach of the T-GENVIH-002 Study. |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Sub-population of Minimally Invasive Surgical Approach of the T-GENVIH-002 Study. |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 5 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Sub-population of Minimally Invasive Surgical Approach of the T-GENVIH-002 Study. |
|---|---|
| United States | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2023 to primary completion in Jan 2024, 4 months.
Results were first posted in May 2025, 1 year 4 months after primary completion.
Of 20 observational studies under Hernia, Ventral, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 72. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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