Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-28 @ 7:31 AM
Study NCT ID:
NCT04718168
Status:
RECRUITING
Last Update Posted:
2025-01-16
First Post:
2020-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GORE® ENFORM Biomaterial Product Study
Sponsor:
W.L.Gore & Associates
Organization:
Study Overview
Official Title:
GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENF 18-06
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: