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 is studying a special material called GORE® ENFORM Biomaterial used in hernia repair surgeries. It focuses on patients with specific types of hernias to see how well this material works in real-world conditions. The material helps by acting as a supportive patch during surgery, making the repaired area stronger. GORE® ENFORM Biomaterial is a type of synthetic material used in hernia repair surgeries, known for its effectiveness in providing quick, simple, and effective repair of tissue defects in the abdominal wall.

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.

Is the GORE ENFORM Device for Hernia Repair safe for humans?

Research on similar materials, like the GORE SYNECOR Intraperitoneal Biomaterial and Gore Bio-A, suggests they are generally safe for hernia repair, with low complication rates and satisfactory outcomes in patients. ^{1 2 3 4 5}

How is the GORE ENFORM Biomaterial treatment for hernia repair different from other treatments?

The GORE ENFORM Biomaterial is unique because it is a hybrid composite mesh designed for intraperitoneal (inside the abdominal cavity) and preperitoneal (just outside the abdominal cavity) placement, offering flexibility in surgical approach and potentially improving integration with body tissues compared to traditional permanent meshes. ^{1 2 3 5 6}

What data supports the effectiveness of the GORE ENFORM Biomaterial treatment for hernia repair?

Research on similar materials, like the GORE SYNECOR Intraperitoneal Biomaterial, shows positive safety and clinical outcomes for hernia repairs, suggesting that the GORE ENFORM Biomaterial might also be effective for this purpose. ^{1 2 3 4 7}

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

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]

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]

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]

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]

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]

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]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of long-term performance of an intraperitoneal biomaterial in the treatment of ventral hernias. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Long-term Performance of the GORE SYNECOR Intraperitoneal Biomaterial in the Treatment of Inguinal Hernias. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

[Use of PTF prosthesis in hernia in the elderly]. [2006]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Behaviour of a new composite mesh for the repair of full-thickness abdominal wall defects in a rabbit model. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The use of Gore Bio-A in the management of the open abdomen. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

[Biomaterials and hernia surgery. Rationale for using them]. [2013]