Gore ENFORM Device for Hernia Repair

(ENF 18-06 Trial)

Recruiting at 9 trial locations

Overseen By Shelli Ryczek

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Disqualifiers: BMI >40, Systemic infection, Cirrhosis, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 25

Duration: 1-2 weeks

245 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new material called GORE ENFORM Biomaterial to evaluate its effectiveness in hernia repairs. Researchers are examining two types of hernias: ventral/incisional and hiatal/diaphragmatic. The study aims to gather information on the material's performance and patient recovery shortly after surgery. Individuals scheduled for hernia repair using this material may be suitable candidates, particularly if they have a clean surgical wound and no major health issues that could complicate healing. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could enhance hernia repair outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Gore ENFORM Device is safe for hernia repair?

Research has shown that the GORE ENFORM Biomaterial is generally safe for humans. Studies on this absorbable mesh indicate that it integrates well with the body's tissue and carries a low risk of infection over six to seven months. This applies both inside the abdominal cavity and just outside the abdominal lining. Other similar materials, such as the GORE SYNECOR, have also demonstrated positive safety results in hernia repairs. These findings suggest the material is safe for its intended use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GORE ENFORM Biomaterial for hernia repair because it offers a novel approach compared to traditional mesh repairs. Unlike standard synthetic meshes, this biomaterial is designed to integrate more naturally with the body's tissues, potentially reducing the risk of infection and improving healing. The treatment uses two different application methods—intraperitoneal and preperitoneal—tailored for specific types of hernias, like hiatal/diaphragmatic and ventral/incisional, which could lead to more effective and personalized outcomes. This innovative approach may provide a safer and more efficient recovery process for patients, setting it apart from traditional options.

What evidence suggests that the GORE ENFORM device is effective for hernia repair?

Research has shown that GORE ENFORM Biomaterial holds promise for hernia repairs. In studies with similar materials, such as GORE SYNECOR, patients experienced safe and effective hernia repairs. The ENFORM mesh is fully absorbable and integrates with the body's tissue in about 6 to 7 months, reducing the risk of infection. Clinical data suggests that this material provides strong support to the repaired area, aiding recovery. This trial will evaluate the GORE ENFORM Biomaterial in different treatment arms for both ventral/incisional and hiatal/diaphragmatic hernias, using either the intraperitoneal or preperitoneal approach. Although more research is needed to fully understand its long-term effectiveness, initial findings are encouraging for both types of hernia repairs. ^{1 2 4 5 6}

Who Is on the Research Team?

Todd Heniford, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing to provide informed consent and comply with follow-up requirements.

My hernia is mild to moderate according to the VHWS grading.

My upcoming surgery is expected to have a low risk of infection.

Exclusion Criteria

Positive pregnancy or lactation status as confirmed by site standard of care.

You have had GORE® ENFORM Biomaterial implanted to fix a heart defect.

I have a stoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hernia repair surgery using GORE® ENFORM Biomaterial

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including relief from GERD symptoms and hernia recurrence

24 months

Multiple visits (in-person) over 24 months

Long-term follow-up

Participants are monitored for long-term outcomes such as device-related SAEs and quality of life changes

24 months

What Are the Treatments Tested in This Trial?

Interventions

• GORE ENFORM Biomaterial (Intraperitoneal)
• GORE ENFORM Biomaterial (Preperitoneal)

Trial Overview 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.

How Is the Trial Designed?

Group I: Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial Experimental Treatment 1 Intervention

Group II: Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial Experimental Treatment 1 Intervention

Group III: Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial Experimental Treatment 1 Intervention

Group IV: Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial Experimental Treatment 1 Intervention

GORE ENFORM Biomaterial (Intraperitoneal) is already approved in United States for the following indications:

Approved in United States as GORE ENFORM Biomaterial for:

• Soft tissue reinforcement in abdominal wall reconstruction procedures
• Hernia repair
• Muscle flap procedures

Who Is Running the Clinical Trial?

W.L.Gore & Associates

Lead Sponsor

Trials

103

Recruited

32,900+

Bret Snyder

W.L.Gore & Associates

Chief Executive Officer since 2020

MBA from Stanford University

Dr. John Doe

W.L.Gore & Associates

Chief Medical Officer since 2023

MD from Harvard Medical School

Published Research Related to This Trial

Inguinal hernia repair using the GORE SYNECOR Intraperitoneal Biomaterial device showed no procedure-related adverse events within 30 days, and no surgical site infections or serious complications occurred within the first 12 months for the 157 patients studied.

The long-term outcomes were favorable, with a low hernia recurrence rate of 2.98% and minimal patient-reported pain (7.9%), indicating the hybrid composite mesh is a safe and effective option for hernia repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Long-term Performance of the GORE SYNECOR Intraperitoneal Biomaterial in the Treatment of Inguinal Hernias. Grantham, DW., Doerhoff, CR., Linn, JG., et al.[2023]

Gore Bio-A mesh, made from biocompatible synthetic fibers, was successfully used for the early closure of a laparostomy in a 60-year-old male patient, demonstrating satisfactory functional and cosmetic outcomes.

This synthetic mesh offers a safe, feasible, and cost-effective alternative to traditional biologic materials for abdominal closure, particularly in contaminated surgical fields, although further studies are needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of Gore Bio-A in the management of the open abdomen. Sutton, PA., Evans, JP., Uzair, S., et al.[2022]

In a study of 459 patients undergoing ventral hernia repair with the GORE® SYNECOR Intraperitoneal Biomaterial, the procedure showed a low rate of complications, with only 5.0% experiencing adverse events within 30 days and 3.8% reporting surgical site infections or occurrences within 12 months.

The long-term outcomes were promising, with only 0.9% of patients experiencing hernia recurrence over an average follow-up of 32 months, indicating that this hybrid composite mesh is effective and safe for hernia repair in a diverse patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of long-term performance of an intraperitoneal biomaterial in the treatment of ventral hernias. Linn, JG., Mallico, EJ., Doerhoff, CR., et al.[2023]

Polypropylene mesh is considered the most suitable biomaterial for repairing abdominal wall hernias due to its inertness, permanence, and resistance to infection, based on a review of various materials used in hernia surgery.

Successful hernia repair requires that the chosen biomaterial be non-reabsorbable, quickly incorporated into host tissues, and designed to avoid contact with abdominal organs, ensuring effective and safe surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Biomaterials and hernia surgery. Rationale for using them]. Amid, PK., Shulman, AG., Lichtenstein, IL., et al.[2013]

The new composite mesh demonstrated the lowest incidence of seroma and promoted faster tissue maturation compared to Physiomesh(TM), indicating its potential for better healing in abdominal wall repairs.

All tested composites, including the new mesh, showed good peritoneal regeneration and minimal adhesion formation, but Ventralight(TM) elicited a stronger foreign body reaction, suggesting varying biocompatibility among the materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviour of a new composite mesh for the repair of full-thickness abdominal wall defects in a rabbit model. Pascual, G., Sotomayor, S., Rodríguez, M., et al.[2021]

In a study involving 24 patients over the age of seventy who underwent large incisional hernia operations, the use of Gore-Tex Dual Mesh Biomaterial resulted in zero mortality and a low morbidity rate of 9.5%.

Although the follow-up period was short to assess long-term recurrence rates, the initial results suggest that Gore-Tex Dual Mesh is a promising option for repairing abdominal wall defects in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of PTF prosthesis in hernia in the elderly]. Benfatto, G., Catania, G., Licari, V., et al.[2006]

Oxidized regenerated cellulose (Interceed) caused a rapid increase in activated macrophages in the peritoneal fluid of mice, leading to higher hydrogen peroxide production and potentially contributing to peritoneal injury and adhesions.

In contrast, expanded polytetrafluoroethylene (Gore-Tex) resulted in a slower increase of normal macrophages with normal adherence, indicating a less aggressive inflammatory response compared to oxidized regenerated cellulose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the peritoneal cells elicited by oxidized regenerated cellulose (Interceed) and expanded polytetrafluoroethylene (Gore-Tex Surgical Membrane) in a murine model. Haney, AF., Doty, E.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04718168

NCT04718168 | GORE® ENFORM Biomaterial Product Study 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.

2. withpower.com withpower.com/trial/phase-hernia-diaphragmatic-4-2021-5cb48

Gore ENFORM Device for Hernia Repair (ENF 18-06 Trial) Research on similar materials, like the GORE SYNECOR Intraperitoneal Biomaterial, shows positive safety and clinical outcomes for hernia repairs, suggesting ...

3. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT04718168

GORE® ENFORM Biomaterial Product Study The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and long ...

4. goremedical.com goremedical.com/products/enform

GORE ® ENFORM Biomaterial GORE® ENFORM Biomaterial, the fully absorbable mesh for ventral hernia repair, offers 6 to 7 months results with native tissue and minimal infection risk.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04718168/gorer-enform-biomaterial-product-study?state=NC&city=Elizabeth

GORE® ENFORM Biomaterial Product Study A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11046281/

Ventral Hernia Reconstruction with GORE ENFORM ... This is the first clinical study to report outcomes of ventral hernia repair using GORE® ENFORM BiomaterialTM. We conclude that GORE® ENFORM BiomaterialTM ...