Robotic-assisted needle placement in CT-guided percutaneous ablation in the abdomen: the SaFE post-market study

To assess the feasibility, safety, and accuracy of robotic needle placement for abdominal percutaneous interventions in a real-world, post-market setting.

This prospective single-center study assessed a robotic guidance device for CT-guided needle placement during abdominal thermal ablation procedures. The primary endpoint was technical success, defined as successful robotic needle placement without technical failure (full manual insertion or two failed robotic attempts). Secondary endpoints included procedural safety, needle placement accuracy (3D deviation and manual adjustments categorized as minor [depth-only], moderate [lateral], and major [complete needle retrieval]), immediate ablation success, 2-month and 1-year local recurrence, and operator satisfaction (5-point Likert scale).

Between April 2022 and January 2023, 54 patients (one duplicate inclusion excluded) were analyzed (30 men, 24 women); mean age 64.7 (± 12.9). Most had metastatic disease (74.1%). Target organs included mainly the liver (68.5%) and the kidney (24.1%). Mean lesion diameter was 24.7 mm (± 13.1), with 59.0% considered technically challenging. Ablation modalities included microwave (63.3%), cryoablation (35.0%), and radiofrequency (1.7%). A total of 108 needles were placed (mean 1.8/patient), yielding a technical success rate of 94.4%. The mean final 3D accuracy after adjustments when required was 2.5 mm (± 3.7). Immediate ablation success was achieved in 98.4% lesions (60/61), with a mean minimal margin of 5.6 mm (± 3.2). Local recurrence occurred in 8.3% of cases at 2 months and in 25.6% at 1 year. Operator satisfaction averaged 3.1/4.

Robotic guidance for CT-guided abdominal thermal ablation is feasible, safe, and provides high needle placement accuracy. Early oncologic outcomes appear comparable to conventional freehand techniques, supporting the integration of robotic systems into routine interventional radiology practice.