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.