Clinical trial NCT06034652: T-GENVIH-003 LTFU (Long Term Follow Up) 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 8
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Clinically Confirmed Recurrence
timeFrame: Through study completion, an average of 4 months.
Secondary outcomes:
measure: Self-Reported Recurrence
timeFrame: Through study completion, an average of 4 months.
measure: Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI)
timeFrame: Through study completion, an average of 4 months.
measure: Number of Participants With Surgical Site Occurrences (SSOs)
timeFrame: Through study completion, an average of 4 months.
measure: Number of Subjects With Surgical Site Infections (SSIs)
timeFrame: Through study completion, an average of 4 months.
measure: Number of Participants With Self-Reported Recurrence
timeFrame: Through study completion, an average of 4 months.
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Surgical Healing Arts
state: Florida
Study officials:
affiliation: Integra LifeSciences Corporation
name: Adam Young, PhD PMP
role: STUDY_DIRECTOR
References: