NCT04718168 · W.L.Gore & Associates
GORE® ENFORM Biomaterial Product Study
(ENF 18-06)
What this study is about
A forward-looking, reviewing past data, non-randomly assigned, conducted at multiple hospitals 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.
View original scientific 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 short-term patient experience.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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.
- 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.
Where
- San Diego, California
- Denver, Colorado
- Sarasota, Florida
- Evanston, Illinois
- Lexington, Kentucky
- Charlotte, North Carolina
- Greenville, South Carolina
- Houston, Texas
- Milwaukee, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations