gore® enform biomaterial product study

Conditions: Hernia, Ventral; Hernia, Hiatal; Hernia, Diaphragmatic; Incisional Hernia

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.

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.

Keywords: hernia ventral hiatal diaphragmatic incisional mesh gore w.l. gore enform