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Biomaterial
Gore ENFORM Device for Hernia Repair (ENF 18-06 Trial)
N/A
Recruiting
Led By Todd Heniford, MD
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 24 months
Awards & highlights
ENF 18-06 Trial Summary
This trial is testing a new device to see if it works better than current devices for hernia repair.
Who is the study for?
This trial is for adults over 18 with a Grade 1 or 2 ventral or hiatal hernia and a clean surgical wound. Candidates must consent to follow-up, not have a stoma, BMI over 35, systemic infection, cirrhosis/dialysis, be pregnant/lactating, immunocompromised, in another study within the last year or need multiple mesh devices.Check my eligibility
What is being tested?
The GORE® ENFORM Biomaterial product's performance is being studied in two groups of patients: those undergoing ventral/incisional hernia repair and those with diaphragmatic/hiatal hernia repair. It's non-randomized and multicenter to collect real-world data on this device.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include discomfort at the implant site, inflammation or infection risk due to foreign material introduction into the body during surgery.
ENF 18-06 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old or meet my state's age requirement.
Select...
My upcoming surgery is expected to have a low risk of infection.
Select...
I am scheduled for hernia repair with GORE® ENFORM Biomaterial.
Select...
My hernia is mild to moderate according to the VHWS grading.
ENF 18-06 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hernia Recurrence - Primary Device Endpoint
Incidence of SSI - Primary Procedural Endpoint 1
Incidence of SSO - Primary Procedural Endpoint 2
+1 moreSecondary outcome measures
Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3
Freedom from potential device-related SAEs - Secondary endpoint 1
Re-intervention at study-treated location - Secondary Endpoint 2
+1 moreENF 18-06 Trial Design
4Treatment groups
Experimental Treatment
Group I: Ventral/Incisional Hernia - Preperitoneal ENFORM BiomaterialExperimental Treatment1 Intervention
Group II: Ventral/Incisional Hernia - Intraperitoneal ENFORM BiomaterialExperimental Treatment1 Intervention
Group III: Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM BiomaterialExperimental Treatment1 Intervention
Group IV: Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM BiomaterialExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
W.L.Gore & AssociatesLead Sponsor
95 Previous Clinical Trials
28,082 Total Patients Enrolled
2 Trials studying Incisional Hernia
424 Patients Enrolled for Incisional Hernia
Todd Heniford, MDPrincipal InvestigatorWake Forest University Health Sciences
5 Previous Clinical Trials
863 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had GORE® ENFORM Biomaterial implanted to fix a heart defect.I have a stoma.I need treatment for hernias in different parts of my body or multiple mesh devices.My BMI is over 35.You have participated in another study involving medicine or medical devices within the past year.I have a weakened immune system due to HIV, a transplant, or cancer treatment.My hernia is mild to moderate according to the VHWS grading.I am at least 18 years old or meet my state's age requirement.My upcoming surgery is expected to have a low risk of infection.I am getting a hernia repair that requires a device for support.I have an infection that affects my whole body.I am expected to have a mesh implant during my weight loss or excess skin removal surgery.I have cirrhosis or am undergoing dialysis.I have a condition that affects how my wounds heal.I am scheduled for hernia repair with GORE® ENFORM Biomaterial.
Research Study Groups:
This trial has the following groups:- Group 1: Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial
- Group 2: Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial
- Group 3: Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial
- Group 4: Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Incisional Hernia Patient Testimony for trial: Trial Name: NCT04718168 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients being actively recruited for this research project?
"This clinical trial is currently recruiting patients, as reported on clinicaltrials.gov. The original posting date was 5/17/2021, and the most recent edit was made on 10/5/2022."
Answered by AI
What goals does this scientific investigation hope to achieve?
"Based on the information reported by the trial sponsor, W.L.Gore & Associates, there are several primary and secondary outcomes that will be measured over the course of the study. The primary outcome, which will be measured over a First Post-Procedural Visit (Days 1-45) period, is Incidence of SSI - Primary Procedural Endpoint 1. Further, this study will be evaluating secondary outcomes including Re-intervention at study-treated location - Secondary Endpoint 2, Relief from GERD Symptoms - Secondary Endpoint 4, and Change in Quality of Life in Carolinas Comfort Scale - Secondary End"
Answered by AI
How many research subjects are being recruited for this project?
"The trial sponsor, W.L.Gore & Associates, needs to recruit 245 eligible patients from different study sites in order to move forward with the clinical research. For example, University of Kentucky in Lexington, Kentucky and Froedtert Hospital, Medical College of Wisconsin in Milwaukee, Wisconsin are both participating locations."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
Florida
What site did they apply to?
Atrium Health
Sarasota Memorial HealthCare System
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
when is this going to start?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
iTS GETTING BIGGER. i was hoping for a treatment that would possibly repair or fix the hernia.
PatientReceived 2+ prior treatments
I have a hernia in my throat that i haven't been treated for as of yet and thought a clinical trial might be something to give a try to get treated.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- Sarasota Memorial HealthCare System: < 48 hours
Average response time
- < 2 Days
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