Ventral HerniaNCT05610267

Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair

An observational study of Ventral Hernia, run by Integra LifeSciences Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 22 to 80 years
Conditions the study is for: Ventral Hernia
What is being tested?: Retrospective chart review
Type of treatment: Medical device
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 22 Nov 2022to 28 Dec 2022
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: Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection).

Who may be able to join

Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection)..
Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix.

Who cannot join

Subject has known allergy to porcine-derived products.
Subject required use of Gentrix® device and a second non-Gentrix surgical mesh in the same plane or in different planes for single hernia e.g., Gentrix sublay and a synthetic device in the onlay position.
Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection.
Subject had uncontrolled diabetes, defined as Hb1AC value >7% within 12 weeks prior to index procedure.
Subject has been diagnosed with cirrhosis and/or ascites.

Trial locations and contacts

1 site in 1 country.

United States1 site

Surgical Healing Arts Center
Fort Myers, Florida, 33912

Other trials in United States

About this study

Official title: A Retrospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair

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.

Read the detailed description

Retrospective data will be collected and assessed for early post-operative surgical site events and complications in the immediate post-operative period of 90 days.

Conditions: Ventral Hernia
Being tested: Retrospective chart review
Medical subject headings: Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Retrospective chart reviewDevice
The retrospective chart review will include the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for achart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and present (90 days prior to the start of data collection).

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure
Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure
Measured: 90 days

Secondary outcomes (5)

Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure
Percentage of subjects with an early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure
Measured: 90 days
Incidence of Surgical Site Infections (SSIs) Post Index Procedure
Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure
Measured: 90 days
Incidence of Later Post-operative Complications After 90 Days Post Index Procedure
Percentage of subjects with a later post-operative complications after 90 days post index procedure
Measured: 1 year
Incidence of Hernia Recurrence Confirmed by Clinical Assessment
Percentage of subjects with a hernia recurrence confirmed by clinical assessment
Measured: 1 year
Incidence of Reoperation Requirement Due to Index Repair
Percentage of subjects with a reoperation requirement due to index repair
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Nov 202228 Dec 2022

First posted9 Nov 2022
Study start22 Nov 2022
Primary completion28 Dec 2022
Study completion28 Dec 2022

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 Ventral 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: Retrospective
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05610267
Sponsor's protocol ID: T-GENVIH-002
Status last verified: Jun 2024
First submitted: 2 Nov 2022
Last updated: 18 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia

All Ventral Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
ClinicalTrials.gov ID: NCT05610267
Acronym / sponsor ID: T-GENVIH-002
Conditions: Ventral Hernia
Study type: Observational
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Study start: 22 Nov 2022 (actual)
Primary completion: 28 Dec 2022 (actual)
Study completion: 28 Dec 2022 (actual)
First posted: 9 Nov 2022 (actual)
Results: Posted 18 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Retrospective data will be collected and assessed for early post-operative surgical site events and complications in the immediate post-operative period of 90 days.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 22 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection).

Key inclusion criteria (2 listed)

Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection)..
Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix.

Key exclusion criteria (5 listed)

Subject has known allergy to porcine-derived products.
Subject required use of Gentrix® device and a second non-Gentrix surgical mesh in the same plane or in different planes for single hernia e.g., Gentrix sublay and a synthetic device in the onlay position.
Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection.
Subject had uncontrolled diabetes, defined as Hb1AC value >7% within 12 weeks prior to index procedure.
Subject has been diagnosed with cirrhosis and/or ascites.

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
Retrospective chart reviewThe retrospective chart review will include the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for achart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and present (90 days prior to the start of data collection).	Device	–

Primary outcome

Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure
Time frame: 90 days
Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure

5 secondary outcomes

Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure
Time frame: 90 days
Incidence of Surgical Site Infections (SSIs) Post Index Procedure
Time frame: 90 days
Incidence of Later Post-operative Complications After 90 Days Post Index Procedure
Time frame: 1 year
Incidence of Hernia Recurrence Confirmed by Clinical Assessment
Time frame: 1 year
Incidence of Reoperation Requirement Due to Index Repair
Time frame: 1 year

Results and safety

Results posted to the registry on 18 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Device: Retrospective Chart Review	28	28

Primary outcome: Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure

Time frame: 90 days. Count of participants. Unit: Participants

Measure	Device: Retrospective Chart Review n = 28
Value	2

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device: Retrospective Chart Review	3 of 28 (10.7%)	13 of 28 (46.4%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Ventral Hernia

Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia

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, MD 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 Ventral Hernia, 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 2 inclusion and 5 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 18 Jun 2024. 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 18 Jun 2024). 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?

Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05610267.

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 18 Jun 2024.