GORE® ENFORM Biomaterial Product Study
Purpose
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.
Conditions
- Hernia, Ventral
- Hernia, Hiatal
- Hernia, Diaphragmatic
- Incisional Hernia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial |
|
|
Experimental Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial |
|
|
Experimental Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial |
|
|
Experimental Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial |
|
Recruiting Locations
San Diego, California 92093
Denver, Colorado 80124
Sarasota, Florida 34239
Evanston, Illinois 60201
Lexington, Kentucky 40506
Charlotte, North Carolina 28204
Greenville, South Carolina 29615
Houston, Texas 77401
Milwaukee, Wisconsin 53226
More Details
- NCT ID
- NCT04718168
- Status
- Recruiting
- Sponsor
- W.L.Gore & Associates
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.