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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 4 months. |
| Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Adam Young, PhD PMP | Integra LifeSciences Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical Healing Arts | Fort Myers | Florida | 33912 | United States |
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Non-applicable.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Statistical Analysis will be based on data from all evaluable subjects meeting the eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sub-population of Minimally Invasive Surgical Approach of the T-GENVIH-002 Study. | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention. | Posted | Count of Participants | Participants | Through study completion, an average of 4 months. |
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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.
[Adverse Event reporting aligns with clinicaltrial.gov definitions]
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Tummon, Director, Global Clinical Operations | Integra LifeSciences Corporation | 609-936-5490 | andrew.tummon@integralife.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2023 | Jan 2, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2023 | May 28, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| D006555 | Hernia, Ventral |
| D020763 | Pathological Conditions, Anatomical |
| D046449 | Hernia, Abdominal |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) of the primary hernia repair to date, including not previously reported in T-GENVIH-002. |
| 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. | 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. | 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. | Through study completion, an average of 4 months. |
| Years |
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| Sex: Female, Male | 8 out of a possible 21 pre-identified subjects (retrospective) met eligibility criteria. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention. | Posted | Count of Participants | Participants | Through study completion, an average of 4 months. |
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| Secondary | 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. | Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention. | Posted | Count of Participants | Participants | Through study completion, an average of 4 months. |
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| Secondary | 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. | Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention. | Posted | Count of Participants | Participants | Through study completion, an average of 4 months. |
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| Secondary | 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. | Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention. | Posted | Count of Participants | Participants | Through study completion, an average of 4 months. |
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| Secondary | 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. | Intent-to-Treat (ITT) Population: All subjects who are enrolled into the study provide informed consent waiver and receive study intervention. | Posted | Count of Participants | Participants | Through study completion, an average of 4 months. |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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