Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-06 @ 9:44 PM
Study NCT ID:
NCT02369692
Status:
TERMINATED
Last Update Posted:
2018-03-01
First Post:
2015-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Embolization Procedures in the Peripheral Vasculature Using the Magellan™ Robotic System
Sponsor:
Hansen Medical
Organization:
Study Overview
Official Title:
Embolization Procedures in the Peripheral Vasculature Using the Magellan™ Robotic System
Status:
TERMINATED
Status Verified Date:
2015-09
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:
None
Brief Summary:
The purpose of this prospective study is to gather procedural use and safety data on the initial use of the Magellan Robotic System with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver This study will focus on, but not be limited to, endovascular embolization procedures in the peripheral vascular, for example, embolization of the splenic and hepatic arteries, uterine arterial embolization (UAE), prostatic arterial embolization (PAE), and trans-arterial chemoembolization (TACE).
The data will be analyzed for medical education, societal presentation and/or publication by the investigator.
The data will be analyzed for medical education, societal presentation and/or publication by the investigator.
Detailed Description:
The primary objectives of this study are to evaluate the safety and clinical performance of the Magellan Robotic System with the 6 Fr catheter, Vascular Accessories 6 Fr and Microcatheter Driver in patients who are indicated for an embolization procedure or other endovascular procedure in the peripheral vasculature.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: