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