Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453642
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-29
Brief Title:
Evaluation of a Simple-Prep Controlled Embolic
Sponsor:
Fluidx Medical Technology Inc
Organization:
Fluidx Medical Technology Inc
Study Overview
Official Title:
Evaluation of a Simple-Prep Controlled Embolic GPX Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
GPX
Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of the GPX Embolic Device when used as indicated for embolization requiring distal vessel penetration in 114 subjects in up to 25 investigational sites in the USA New Zealand and Canada
Detailed Description:
The investigation is a single-arm open-label non-randomized prospective multicenter multinational pivotal study Subjects will undergo distal embolization in the peripheral vasculature including vascular tumors renal embolizations and portal vein branches with the GPX Embolic Device and will then be followed 30-days post-procedure
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None