Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT06141694
Status:
COMPLETED
Last Update Posted:
2024-10-17
First Post:
2023-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Clin. Capabilities of LIBERTY® Endovascular Robotic System's Performance & Safety in Periph. Vasc. Interv.
Sponsor:
Microbot Medical, INC
Organization:
Study Overview
Official Title:
Assessment of Clinical Capabilities of LIBERTY® Endovascular Robotic System's Performance and Safety in Peripheral Vascular Interventions: A Multi-Center, Single Arm, Prospective Trial (ACCESS-PVI)
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCESS-PVI
Brief Summary:
A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions. The study is designed to evaluate the performance and safety of endovascular procedures supported by the LIBERTY® Robotic System. The System is configured to deliver and manipulate third-party commercially available surgical devices that are employed in endovascular transcatheter procedures (guidewires, microcatheters, and guiding catheters).
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?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: