Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-02 @ 6:08 AM
Study NCT ID:
NCT04950959
Status:
RECRUITING
Last Update Posted:
2022-10-21
First Post:
2021-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
XACT ACE Observational Registry
Sponsor:
Xact Robotics Ltd.
Organization:
Study Overview
Official Title:
Observational Post-Market Study of the XACT ACE Robotic System
Status:
RECRUITING
Status Verified Date:
2022-10
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:
Compile real world data on the use of the XACT ACE Robotic System
Detailed Description:
The purpose of this observational post-market study is to compile real world data on the use of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures.
The objectives are to 1) evaluate the proportion of procedures in which the instrument reached the pre-defined target, based on the physician's determination and CT imaging confirmation, 2) To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the at the end of the instrument insertion, and 3) Incidence of intra- and post-procedural adverse events.
Up to 500 patients will be enrolled in this multicenter, nonrandomized, single arm registry.
The objectives are to 1) evaluate the proportion of procedures in which the instrument reached the pre-defined target, based on the physician's determination and CT imaging confirmation, 2) To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the at the end of the instrument insertion, and 3) Incidence of intra- and post-procedural adverse events.
Up to 500 patients will be enrolled in this multicenter, nonrandomized, single arm registry.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: