HerniaNCT06034652
T-GENVIH-003 LTFU (Long Term Follow Up) Study
An observational study of Hernia and Hernia, Ventral, run by Integra LifeSciences Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Hernia, Hernia, Ventral, Pathological Conditions, Anatomical
- What is being tested?
- Integra® Gentrix® Surgical Matrix
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2023to 19 Jan 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Not applicable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair as Long Term Follow Up to T-GENVIH-002 Study
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.
Read the 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.
- Being tested
- Integra® Gentrix® Surgical Matrix
- Medical subject headings
- Hernia, Hernia, Ventral, Pathological Conditions, Anatomical, Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integra® Gentrix® Surgical MatrixDevice
Integra® Gentrix® Surgical Matrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic \& reconstructive surgery.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Analysis of Minimally Invasive Surgical Approach (i.e., laparoscopic or robotic) | 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. Receives: Device: Integra® Gentrix® Surgical Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Confirmed Recurrence
- Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
Measured: Through study completion, an average of 4 months.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start12 Sep 2023
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Young, PhD PMP, Study director, Integra LifeSciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034652
- Sponsor's protocol ID
- T-GENVIH-003
- Status last verified
- May 2025
- First submitted
- 6 Sep 2023
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair as Long Term Follow Up to T-GENVIH-002 Study
- ClinicalTrials.gov ID
- NCT06034652
- Acronym / sponsor ID
- T-GENVIH-003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Analysis of Minimally Invasive Surgical Approach (i.e., laparoscopic or robotic) | – | Device: Integra® Gentrix® Surgical MatrixCollection 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. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integra® Gentrix® Surgical MatrixIntegra® Gentrix® Surgical Matrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic \& reconstructive surgery. | Device | Prospective Analysis of Minimally Invasive Surgical Approach (i.e., laparoscopic or robotic) |
Primary outcome
Number of Participants With Clinically Confirmed Recurrence
Time frame: 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.
5 secondary outcomes
Self-Reported Recurrence
Time frame: Through study completion, an average of 4 months.
Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI)
Time frame: Through study completion, an average of 4 months.
Number of Participants With Surgical Site Occurrences (SSOs)
Time frame: Through study completion, an average of 4 months.
Number of Subjects With Surgical Site Infections (SSIs)
Time frame: Through study completion, an average of 4 months.
Number of Participants With Self-Reported Recurrence
Time frame: Through study completion, an average of 4 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Young, PhD PMP study director
Integra LifeSciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia and Hernia, Ventral, run by Integra LifeSciences Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinically Confirmed Recurrence (time frame: Through study completion, an average of 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.