Compile real world data on the use of the XACT ACE Robotic System
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.
Study Type
OBSERVATIONAL
Enrollment
500
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. The XACT ACE Robotic System uses a computerized quantitative guidance system, which provides real-time, accurate needle guidance, including advancement and steering of the needle from the entry point on the subject's body to the target point within the body.
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
RECRUITINGProportion of successful procedures
To evaluate the proportion of procedures in which the instrument reached the pre-defined target based on the physician's determination and CT imaging confirmation.
Time frame: 1 hour
System accuracy
To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the end of the instrument insertion.
Time frame: 1 hour
Assessment of Safety
Incidence of intra- and post-procedural events
Time frame: 2 hours post-procedure
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