Clinical trial NCT04718168: GORE® ENFORM Biomaterial Product Study
Official title: GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hernia, Ventral
Hernia, Hiatal
Hernia, Diaphragmatic
Incisional Hernia
Keywords: hernia
ventral
hiatal
diaphragmatic
incisional
mesh
Gore
W.L. Gore
Enform
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Pre-procedure Inclusion Criteria:

The subject is / has:

1. At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
2. An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
5. Willing to provide informed consent and comply with follow-up requirements.

Pre-procedure Exclusion Criteria:

The subject is / has:

1. Treated in another drug or medical device study within 1 year of study enrollment.
2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
3. 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).
4. A BMI \>40.
5. Evidence of a systemic infection.
6. Cirrhosis or undergoing dialysis.
7. A wound-healing disorder.
8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
9. Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
10. A stoma.
11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
12. Positive pregnancy or lactation status as confirmed by site standard of care.
13. 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:

1. At least 18 years old. Minimum age required by state regulations (as applicable).
2. 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.
3. 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:

1. Treated in another drug or medical device study within 1 year of study enrollment.
2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
3. 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).
4. A BMI \>40.
5. Evidence of a systemic infection.
6. Cirrhosis or undergoing dialysis.
7. A wound-healing disorder.
8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
9. Underwent mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
10. A stoma.
11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
12. Positive pregnancy or lactation status as confirmed by site standard of care.
13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.

Primary outcomes:
measure: Hernia Recurrence - Primary Device Endpoint
timeFrame: Through 24 months
measure: Incidence of SSI - Primary Procedural Endpoint 1
timeFrame: First Post-Procedural Visit (Days 1-45)
measure: Incidence of SSO - Primary Procedural Endpoint 2
timeFrame: First Post-Procedural Visit (Days 1-45)
measure: Incidence of SSOPI - Primary Procedural Endpoint 3
timeFrame: First Post-Procedural Visit (Days 1-45)
Secondary outcomes:
measure: Freedom from potential device-related SAEs - Secondary endpoint 1
timeFrame: Through 24 months
measure: Re-intervention at study-treated location - Secondary Endpoint 2
timeFrame: Through 24 months
measure: Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3
timeFrame: Through 24 months
measure: Relief from GERD Symptoms - Secondary Endpoint 4
timeFrame: Through 24 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California - San Diego
state: California
city: Denver
country: United States
facility: Institute of Esophageal and Reflux Surgery
state: Colorado
city: Sarasota
country: United States
facility: Sarasota Memorial HealthCare System
state: Florida
city: Evanston
country: United States
facility: Northshore University Health System Research Institute
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Greenville
country: United States
facility: Prisma Health - Upstate
state: South Carolina
city: Houston
country: United States
facility: University of Texas Health Science Center at Houson
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Todd Heniford, MD
role: PRINCIPAL_INVESTIGATOR
References: