Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06712251
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2024-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access
Sponsor:
Venova Medical
Organization:
Study Overview
Official Title:
Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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:
VENOS-2
Brief Summary:
The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: