Stereotactic Accuracy and Operative Metrics Utilizing the ClearPoint Frameless Intraoperative-CT Image-Based Guidance: A Multi-Institution Analysis

INTRODUCTION: MRI-guided stereotaxy provides high accuracy but is limited by the need for an interventional/intraoperative MRI environment and associated workflow complexity. ClearPoint Software v3.0 extends an established stereotactic workflow to a conventional operating room using intraoperative CT (iCT) imaging. OBJECTIVE: To evaluate stereotactic accuracy and operative metrics of the ClearPoint frameless iCT image-guided system for deep brain stimulation (DBS) lead implantation. METHODS: We performed a multi-center retrospective review of consecutive DBS lead placement procedures supported by ClearPoint Neuro Navigation System Software Version 3.0 across 7 sites during a limited market release (February 1, 2025-May 1, 2025). Primary outcomes were radial targeting error (distance between planned trajectory endpoint and final device tip position in X-Y) and operative duration (skin incision to closure). RESULTS: Twenty-three procedures were analyzed. Median age was 67 years (range 39-89). Most cases were bilateral (87%, n=20). Targets included subthalamic nucleus (39%, n=9), ventral intermediate nucleus (39%, n=9), and globus pallidus internus (22%, n=5). Targeting accuracy was high, with median radial error of 0.20 mm on the left (range 0-1.60) and 0.20 mm on the right (range 0-1.0). Median operative duration was 203 minutes (range 125-330). Median intraoperative scans were 6, and procedures required a median of 2 adjustments per side. CONCLUSION: In this first multi-institution report of ClearPoint Software v3.0 for DBS lead placement, the frameless iCT workflow demonstrated consistent submillimeter accuracy with favorable operative metrics in a standard operating room setting.