Abstract

Abstract BACKGROUND Laser interstitial thermal therapy (LITT) has advanced the surgical treatment of brain cancer. However, technical constraints in the first-generation laser ablation systems limit the full potential of this technology. ClearPoint Prism® Laser Ablation System was developed to overcome many of these limitations, including a larger ablation window, a faster refresh rate for magnetic resonance thermometry, and integration with an MRI-compatible stereotactic system. This system was FDA cleared for neurosurgical use in 2022. METHODS We prospectively followed the first three patients who underwent LITT using the ClearPoint Prism® Laser Ablation System in the U.S. to establish feasibility and safety of this technology platform. RESULTS Three patients underwent procedures involving MRI-guided needle biopsy followed by LITT. The radial error of stereotaxis relative to the intended target ranged 0.8-1.6 mm (with a median of 1.0 mm). Definitive diagnosis was achieved in all cases. The average time required to establish the trajectories was 98.7 + 16.6 minutes. The average time required to perform the biopsy and LITT was 110 + 19.3 minutes. These times are not statistically different from our published results for comparable procedures using other available LITT systems. The average LITT time required to achieve ablation of > 1cm radius was 49 seconds (range: 29-133 seconds). There were no procedural complications. All patients were discharged home by postoperative day three. The postoperative MRIs demonstrated expected ablation findings consistent with intraoperative thermometric assessment. With a median follow-up of 219 days (range: 185-259 days), there were no 30-day readmission, 90-day emergency visits, or wound complications. CONCLUSION In this study, we provide the clinical outcome of the first three patients in the U.S. who underwent LITT through the FDA cleared ClearPoint Prism® Laser Ablation System. The system has distinct advantages that warrant consideration in further investigations and clinical applications.

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