Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04651517
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2020-11-17
Brief Title:
Pilot Study of the ACE System in Lung Procedures
Sponsor:
Xact Robotics Ltd
Organization:
Xact Robotics Ltd
Study Overview
Official Title:
Pilot Study of the XACT Robotics ACE System for Image Guided Percutaneous Procedures in the Lung
Status:
COMPLETED
Status Verified Date:
2021-08
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:
None
Brief Summary:
To evaluate the XACT ACE Robotic System in lung procedures
Detailed Description:
The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography CT guided percutaneous lung procedures The system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument such as a needle where CT imaging is used for target trajectory planning and intraoperative tracking This study will evaluate safety and accuracy of the XACT ACE Robotic System in subjects undergoing CT guided minimally invasive percutaneous procedures of the lung in the interventional radiology suite
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