Hernia, Diaphragmatic, Hernia, Hiatal, Hernia, Ventral, Incisional Hernia
Conditions
Keywords
hernia, ventral, hiatal, diaphragmatic, incisional, mesh, Gore, W.L. Gore, Enform
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.
Interventions
DEVICEGore ENFORM Biomaterial (Preperitoneal)
ENFORM Biomaterial bioabsorbable hernia mesh
DEVICEGore ENFORM Biomaterial (Intraperitoneal)
ENFORM Biomaterial bioabsorbable hernia mesh
Sponsors
W.L.Gore & Associates
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia Recurrence - Primary Device Endpoint | Through 24 months | Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure). |
| Incidence of SSI - Primary Procedural Endpoint 1 | First Post-Procedural Visit (Days 1-45) | Incidence of SSI, reported as a composite and individually. |
| Incidence of SSO - Primary Procedural Endpoint 2 | First Post-Procedural Visit (Days 1-45) | Incidence of SSO, reported as a composite and individually. |
| Incidence of SSOPI - Primary Procedural Endpoint 3 | First Post-Procedural Visit (Days 1-45) | Incidence of SSOPI, reported as a composite and individually. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from potential device-related SAEs - Secondary endpoint 1 | Through 24 months | Freedom from potential device-related Serious Adverse Events will be reported descriptively with no formal goals or hypothesis. |
| Re-intervention at study-treated location - Secondary Endpoint 2 | Through 24 months | Surgical re-intervention in the area of the hernia repaired initially (e.g. drain insertion, infection, surface issues, second operation, etc.) will be reported descriptively with no formal goals or hypothesis. |
| Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3 | Through 24 months | For ventral hernia subjects; change in Quality of Life in Carolinas Comfort Scale as measured by a change in total score of the Carolinas Comfort Scale Quality of Life questionnaire given at follow-up visits. Minimum Total Score is 0 and maximum Total Score is 115. Lower score means better outcome. |
| Relief from GERD Symptoms - Secondary Endpoint 4 | Through 24 months | For diaphragmatic hernia subjects; relief from GERD symptoms as measured by a decrease in the total score of the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire given at follow-up visits. Total Score: Calculated by summing the individual scores to questions 1-15. Greatest possible score (worst symptoms) = 75 Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6. Worst heartburn symptoms = 30 No heartburn symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions 10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination. |
Countries
United States
Contacts
CONTACTHeidie Hornstra O'Neill
PRINCIPAL_INVESTIGATORTodd Heniford, MD
Endeavor Health
Outcome results
None listed