Hernia, VentralENF 18-06NCT04718168
GORE® ENFORM Biomaterial Product Study
A study testing Gore ENFORM Biomaterial (Preperitoneal) and Gore ENFORM Biomaterial (Intraperitoneal) in people with Hernia, Ventral and Hernia, Hiatal, run by W.L.Gore & Associates at 9 sites in United States.
Trial summary
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic
- What is being tested?
- Gore ENFORM Biomaterial (Preperitoneal) and Gore ENFORM Biomaterial (Intraperitoneal)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 May 2021to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Pre-procedure Inclusion Criteria:
The subject is / has:
- 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.
- A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
- An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
- Willing to provide informed consent and comply with follow-up requirements.
Pre-procedure Exclusion Criteria:
The subject is / has:
- Treated in another drug or medical device study within 1 year of study enrollment.
- Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
- Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).
- A BMI >40.
- Evidence of a systemic infection.
- Cirrhosis or undergoing dialysis.
- A wound-healing disorder.
- Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
- Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
- A stoma.
- Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
- Positive pregnancy or lactation status as confirmed by site standard of care.
- Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.
Post-procedure Inclusion Criteria
At the time of index procedure, the subject is / has:
- At least 18 years old. Minimum age required by state regulations (as applicable).
- Implanted with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture-line reinforcement on or before 365 days prior to site protocol amendment 3 approval date.
- Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject.
Post-procedure Exclusion Criteria
At the time of index procedure, the subject is / has:
- Treated in another drug or medical device study within 1 year of study enrollment.
- Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
- Hernia repair that was performed as part of a bridged procedure (i.e., inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).
- A BMI >40.
- Evidence of a systemic infection.
- Cirrhosis or undergoing dialysis.
- A wound-healing disorder.
- Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
- Underwent mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
- A stoma.
- Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
- Positive pregnancy or lactation status as confirmed by site standard of care.
- Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 7 recruiting
- Completed
Atrium Health
Charlotte, North Carolina, 28204
- Recruiting
Institute of Esophageal and Reflux Surgery
Denver, Colorado, 80124
Philip Woodworth, MD
- Recruiting
Northshore University Health System Research Institute
Evanston, Illinois, 60201
JoAnn Carbray, CCRP, 847-570-3802, jcarbray@northshore.org
Michael Ujiki, MD
- Recruiting
Prisma Health - Upstate
Greenville, South Carolina, 29615
Abby Birrell, 864-522-2117, abby.birrell@prismahealth.org
Jeremy Warren, MD
- Recruiting
University of Texas Health Science Center at Houson
Houston, Texas, 77401
Elaine Tran, 713-486-1346, Elaine.Tran@uth.tmc.edu
Angilyn R. Rivera, 713-486-1350, Angielyn.R.Rivera@uth.tmc.edu
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Anna Rockich, PharmD, 610-212-1086, arockich@uky.edu
Sydney Cloyd, RN, BSN, 859-218-5151, Sydney.Cloyd@uky.edu
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Krissa Packard, MS, ACRP-CP, 414-955-1861, kpackard@mcw.edu
Matthew Goldblatt, MD
- Recruiting
University of California - San Diego
San Diego, California, 92093
Graham J. Spurzem, MD, 831-537-8815, gspurzem@health.ucsd.edu
Ryan Broderick, MD
- Completed
Sarasota Memorial HealthCare System
Sarasota, Florida, 34239
About this study
Official title: GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.
Read the detailed description
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and long-term follow up.
- Being tested
- Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal)
- Keywords
- hernia, ventral, hiatal, diaphragmatic, incisional, mesh, Gore, W.L. Gore, Enform
- Medical subject headings
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia, Hernia, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gore ENFORM Biomaterial (Preperitoneal)Device
ENFORM Biomaterial bioabsorbable hernia mesh
Gore ENFORM Biomaterial (Intraperitoneal)Device
ENFORM Biomaterial bioabsorbable hernia mesh
| Study group | Role | What they receive |
|---|---|---|
| Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial | Experimental | Not described Receives: Device: Gore ENFORM Biomaterial (Preperitoneal) |
| Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial | Experimental | Not described Receives: Device: Gore ENFORM Biomaterial (Intraperitoneal) |
| Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial | Experimental | Not described Receives: Device: Gore ENFORM Biomaterial (Preperitoneal) |
| Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial | Experimental | Not described Receives: Device: Gore ENFORM Biomaterial (Intraperitoneal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Recurrence - Primary Device Endpoint
Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure).
Measured: Through 24 months
Incidence of SSI - Primary Procedural Endpoint 1
Incidence of SSI, reported as a composite and individually.
Measured: First Post-Procedural Visit (Days 1-45)
Incidence of SSO - Primary Procedural Endpoint 2
Incidence of SSO, reported as a composite and individually.
Measured: First Post-Procedural Visit (Days 1-45)
Incidence of SSOPI - Primary Procedural Endpoint 3
Incidence of SSOPI, reported as a composite and individually.
Measured: First Post-Procedural Visit (Days 1-45)
Secondary outcomes (4)
Freedom from potential device-related SAEs - Secondary endpoint 1
Freedom from potential device-related Serious Adverse Events will be reported descriptively with no formal goals or hypothesis.
Measured: Through 24 months
Re-intervention at study-treated location - Secondary Endpoint 2
Surgical re-intervention in the area of the hernia repaired initially (e.g. drain insertion, infection, surface issues, second operation, etc.) will be reported descriptively with no formal goals or hypothesis.
Measured: Through 24 months
Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3
For ventral hernia subjects; change in Quality of Life in Carolinas Comfort Scale as measured by a change in total score of the Carolinas Comfort Scale Quality of Life questionnaire given at follow-up visits.
Minimum Total Score is 0 and maximum Total Score is 115. Lower score means better outcome.
Measured: Through 24 months
Relief from GERD Symptoms - Secondary Endpoint 4
For diaphragmatic hernia subjects; relief from GERD symptoms as measured by a decrease in the total score of the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire given at follow-up visits.
Total Score: Calculated by summing the individual scores to questions 1-15. Greatest possible score (worst symptoms) = 75 Lowest possible score (no symptoms) = 0
Heartburn Score: Calculated by summing the individual scores to questions 1-6. Worst heartburn symptoms = 30 No heartburn symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination.
Regurgitation Score: Calculated by summing the individual scores to questions 10-15.
Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
Measured: Through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start17 May 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Heniford, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718168
- Sponsor's protocol ID
- ENF 18-06
- Acronym
- ENF 18-06
- Status last verified
- Jul 2026
- First submitted
- 24 Aug 2020
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients
- ClinicalTrials.gov ID
- NCT04718168
- Acronym / sponsor ID
- ENF 18-06 / ENF 18-06
- Keywords
- hernia, ventral, hiatal, diaphragmatic, incisional, mesh, Gore, W.L. Gore
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 17 May 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.
Detailed description
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and long-term follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial | Experimental | Device: Gore ENFORM Biomaterial (Preperitoneal) |
| Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial | Experimental | Device: Gore ENFORM Biomaterial (Intraperitoneal) |
| Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial | Experimental | Device: Gore ENFORM Biomaterial (Preperitoneal) |
| Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial | Experimental | Device: Gore ENFORM Biomaterial (Intraperitoneal) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Gore ENFORM Biomaterial (Preperitoneal)ENFORM Biomaterial bioabsorbable hernia mesh | Device | Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial, Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial |
| Gore ENFORM Biomaterial (Intraperitoneal)ENFORM Biomaterial bioabsorbable hernia mesh | Device | Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial, Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial |
Primary outcome
Hernia Recurrence - Primary Device Endpoint
Time frame: Through 24 months
Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure).
Incidence of SSI - Primary Procedural Endpoint 1
Time frame: First Post-Procedural Visit (Days 1-45)
Incidence of SSI, reported as a composite and individually.
Incidence of SSO - Primary Procedural Endpoint 2
Time frame: First Post-Procedural Visit (Days 1-45)
Incidence of SSO, reported as a composite and individually.
Incidence of SSOPI - Primary Procedural Endpoint 3
Time frame: First Post-Procedural Visit (Days 1-45)
Incidence of SSOPI, reported as a composite and individually.
4 secondary outcomes
Freedom from potential device-related SAEs - Secondary endpoint 1
Time frame: Through 24 months
Re-intervention at study-treated location - Secondary Endpoint 2
Time frame: Through 24 months
Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3
Time frame: Through 24 months
Relief from GERD Symptoms - Secondary Endpoint 4
Time frame: Through 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Hernia, Ventral
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Not yet recruiting
The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery
Ventral Hernia, Ventral Incisional Hernia
Active, not recruitingObservational study
ORION Study: Mesh Position and Risk During Subsequent Minimally Invasive Abdominal Surgery
Ventral Hernia Repair
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.
Todd Heniford, MD principal investigator
Endeavor Health
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gore ENFORM Biomaterial (Preperitoneal) and Gore ENFORM Biomaterial (Intraperitoneal) in people with Hernia, Ventral and Hernia, Hiatal, run by W.L.Gore & Associates at 9 sites 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?
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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidie Hornstra O'Neill (443-907-3152, hhornstr@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia Recurrence - Primary Device Endpoint (time frame: Through 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.