GORE® ENFORM Biomaterial Product Study

Study Overview
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Brief Summary
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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.

Official Title
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GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients

Conditions
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Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia

Intervention / Treatment
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* Device: Gore ENFORM Biomaterial (Preperitoneal)
* Device: Gore ENFORM Biomaterial (Intraperitoneal)


Participation Criteria
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Eligibility Criteria
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Pre-procedure Inclusion Criteria: The subject is / has: At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable). An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system. Willing to provide informed consent and comply with follow-up requirements. Pre-procedure Exclusion Criteria: The subject is / has: Treated in another drug or medical device study within 1 year of study enrollment. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects. 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). A BMI >40. Evidence of a systemic infection. Cirrhosis or undergoing dialysis. A wound-healing disorder. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy. Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure. A stoma. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements. Positive pregnancy or lactation status as confirmed by site standard of care. 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: At least 18 years old. Minimum age required by state regulations (as applicable). 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. 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: Treated in another drug or medical device study within 1 year of study enrollment. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects. 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). A BMI >40. Evidence of a systemic infection. Cirrhosis or undergoing dialysis. A wound-healing disorder. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy. Underwent mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure. A stoma. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements. Positive pregnancy or lactation status as confirmed by site standard of care. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial<br> | Device: Gore ENFORM Biomaterial (Preperitoneal)<br>* ENFORM Biomaterial bioabsorbable hernia mesh<br>|
| Experimental: Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial<br> | Device: Gore ENFORM Biomaterial (Intraperitoneal)<br>* ENFORM Biomaterial bioabsorbable hernia mesh<br>|
| Experimental: Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial<br> | Device: Gore ENFORM Biomaterial (Preperitoneal)<br>* ENFORM Biomaterial bioabsorbable hernia mesh<br>|
| Experimental: Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial<br> | Device: Gore ENFORM Biomaterial (Intraperitoneal)<br>* ENFORM Biomaterial bioabsorbable hernia mesh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia Recurrence - Primary Device Endpoint | Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure). | Through 24 months | 
| Incidence of SSI - Primary Procedural Endpoint 1 | Incidence of SSI, reported as a composite and individually. | First Post-Procedural Visit (Days 1-45) | 
| Incidence of SSO - Primary Procedural Endpoint 2 | Incidence of SSO, reported as a composite and individually. | First Post-Procedural Visit (Days 1-45) | 
| Incidence of SSOPI - Primary Procedural Endpoint 3 | Incidence of SSOPI, reported as a composite and individually. | First Post-Procedural Visit (Days 1-45) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from potential device-related SAEs - Secondary endpoint 1 | Freedom from potential device-related Serious Adverse Events will be reported descriptively with no formal goals or hypothesis. | Through 24 months | 
| Re-intervention at study-treated location - Secondary Endpoint 2 | 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. | Through 24 months | 
| Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3 | 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. | Through 24 months | 
| Relief from GERD Symptoms - Secondary Endpoint 4 | 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. | Through 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hernia, ventral, hiatal, diaphragmatic, incisional, mesh, Gore, W.L. Gore, Enform