Trial Outcomes & Findings for T-GENVIH-003 LTFU (Long Term Follow Up) Study (NCT NCT06034652)
NCT ID: NCT06034652
Last Updated: 2025-05-20
Results Overview
1\. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
COMPLETED
8 participants
Through study completion, an average of 4 months.
2025-05-20
Participant Flow
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.
Non-applicable.
Participant milestones
| Measure |
Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) From GENVIH-002 Study.
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.
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|---|---|
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
8 out of a possible 21 pre-identified subjects (retrospective) met eligibility criteria.
Baseline characteristics by cohort
| Measure |
Sub-population of Minimally Invasive Surgical Approach of the T-GENVIH-002 Study.
n=8 Participants
Subjects in the study are from the sub-population of minimally invasive surgical approach (e.g., laparoscopic or robotic) of the T-GENVIH-002 study.
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|---|---|
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Age, Continuous
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66.0 Years
STANDARD_DEVIATION 13.47 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants • 8 out of a possible 21 pre-identified subjects (retrospective) met eligibility criteria.
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Sex: Female, Male
Male
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6 Participants
n=5 Participants • 8 out of a possible 21 pre-identified subjects (retrospective) met eligibility criteria.
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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5 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
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Region of Enrollment
United States
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8 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Through study completion, an average of 4 months.Population: Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention.
1\. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
Outcome measures
| Measure |
Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic)
n=8 Participants
Collection of performance data for eight 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.
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.
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|---|---|
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Number of Participants With Clinically Confirmed Recurrence
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2 Participants
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SECONDARY outcome
Timeframe: Through study completion, an average of 4 months.Population: Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention.
Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
Outcome measures
| Measure |
Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic)
n=8 Participants
Collection of performance data for eight 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.
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.
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|---|---|
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Self-Reported Recurrence
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3 Participants
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SECONDARY outcome
Timeframe: Through study completion, an average of 4 months.Population: Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention.
Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) of the primary hernia repair to date, including not previously reported in T-GENVIH-002.
Outcome measures
| Measure |
Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic)
n=8 Participants
Collection of performance data for eight 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.
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.
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|---|---|
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Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI)
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1 Participants
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SECONDARY outcome
Timeframe: Through study completion, an average of 4 months.Population: Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention.
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.
Outcome measures
| Measure |
Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic)
n=8 Participants
Collection of performance data for eight 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.
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.
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|---|---|
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Number of Participants With Surgical Site Occurrences (SSOs)
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1 Participants
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SECONDARY outcome
Timeframe: Through study completion, an average of 4 months.Population: Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention.
Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not previously reported in T-GENVIH-002 study.
Outcome measures
| Measure |
Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic)
n=8 Participants
Collection of performance data for eight 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.
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.
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|---|---|
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Number of Subjects With Surgical Site Infections (SSIs)
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1 Participants
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SECONDARY outcome
Timeframe: Through study completion, an average of 4 months.Population: Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention.
Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
Outcome measures
| Measure |
Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic)
n=8 Participants
Collection of performance data for eight 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.
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.
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|---|---|
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Number of Participants With Self-Reported Recurrence
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8 Participants
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Adverse Events
Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andrew Tummon, Director, Global Clinical Operations
Integra LifeSciences Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place