Observational Post-Market Study of the XACT ACE Robotic System

What this Trial Is About

This research aims to collect real-world data on the use of the XACT ACE Robotic System in patients undergoing CT-guided, minimally invasive percutaneous procedures, often related to tumors. The study focuses on assessing how often the robotic instrument successfully reaches the target, the accuracy of its positioning, and the occurrence of any adverse events during or after the procedures. This is an observational post-market study involving up to 500 patients and is conducted by Xact Robotics Ltd. The study involves the use of the XACT ACE Robotic System, a hands-free, user-controlled device designed to assist physicians by planning the needle trajectory and guiding the instrument accurately from the body entry point to the target inside the body using CT imaging. The device helps in advancing and steering the needle during the procedure, which takes place in an interventional radiology setting. All participants receive this robotic assistance as part of their CT-guided procedure. Participants will be monitored during and shortly after their procedures. Researchers will evaluate the success rate of procedures within one hour, measure system accuracy at the time of instrument placement, and assess safety within two hours post-procedure. Data collection includes physician assessments and CT imaging. The study does not involve randomization or additional treatment beyond the robotic assistance. Participants' involvement primarily concerns consenting to data collection during their standard care procedure.

XACT ACE Observational Registry