The ClearPoint Prism® Laser Ablation System: A New Platform for Laser Interstitial Thermal Therapy (LITT) in Neuro-Oncology.

Abstract

Background and objectives: 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. The 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 US Food and Drug Administration-cleared for neurosurgical use in 2022.

Methods: As an IDEAL Stage 1 study, we prospectively followed the first 3 patients who underwent LITT using the ClearPoint Prism® Laser Ablation System in the United States 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 from 0.8 to 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 >1 cm radius was 49 seconds (range: 29-133 seconds). There were no procedural complications. All patients were discharged home by postoperative day 3. 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 introduced the design rationale for the ClearPoint Prism® Laser Ablation System, theoretical considerations for its technical merits relative to other existing systems, and to share our initial experience.