Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
245 participants
INTERVENTIONAL
2021-05-17
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial
Gore ENFORM Biomaterial (Preperitoneal)
ENFORM Biomaterial bioabsorbable hernia mesh
Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial
Gore ENFORM Biomaterial (Intraperitoneal)
ENFORM Biomaterial bioabsorbable hernia mesh
Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial
Gore ENFORM Biomaterial (Preperitoneal)
ENFORM Biomaterial bioabsorbable hernia mesh
Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial
Gore ENFORM Biomaterial (Intraperitoneal)
ENFORM Biomaterial bioabsorbable hernia mesh
Interventions
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Gore ENFORM Biomaterial (Preperitoneal)
ENFORM Biomaterial bioabsorbable hernia mesh
Gore ENFORM Biomaterial (Intraperitoneal)
ENFORM Biomaterial bioabsorbable hernia mesh
Eligibility Criteria
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Inclusion Criteria
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.
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.
Exclusion Criteria
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.
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.
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Todd Heniford, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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University of California - San Diego
San Diego, California, United States
Institute of Esophageal and Reflux Surgery
Denver, Colorado, United States
Sarasota Memorial HealthCare System
Sarasota, Florida, United States
Northshore University Health System Research Institute
Evanston, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
Atrium Health
Charlotte, North Carolina, United States
Prisma Health - Upstate
Greenville, South Carolina, United States
University of Texas Health Science Center at Houson
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ENF 18-06
Identifier Type: -
Identifier Source: org_study_id
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