Hernia, Hernia, Abdominal, Hernia, Ventral, Pathological Conditions, Anatomical
Conditions
Brief 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.
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.
Interventions
DEVICEIntegra® 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.
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Confirmed Recurrence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Recurrence | Through study completion, an average of 4 months. | Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study. |
| Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI) | Through study completion, an average of 4 months. | Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) of the primary hernia repair to date, including not previously reported in T-GENVIH-002. |
| Number of Participants With Surgical Site Occurrences (SSOs) | Through study completion, an average of 4 months. | 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. |
| Number of Subjects With Surgical Site Infections (SSIs) | Through study completion, an average of 4 months. | Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not previously reported in T-GENVIH-002 study. |
| Number of Participants With Self-Reported Recurrence | Through study completion, an average of 4 months. | Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Non-applicable.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Sub-population of Minimally Invasive Surgical Approach of the T-GENVIH-002 Study. |
|---|---|
| Age, Continuous | 66.0 Years STANDARD_DEVIATION 13.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) | Number of Participants With Clinically Confirmed Recurrence | 2 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) | Number of Participants With Self-Reported Recurrence | 8 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_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 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) | Number of Participants With Surgical Site Occurrences (SSOs) | 1 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) | Number of Subjects With Surgical Site Infections (SSIs) | 1 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Analysis of Minimally Invasive Surgical Approach (i.e., Laparoscopic or Robotic) | Self-Reported Recurrence | 3 Participants |