Efficacy and safety of the RC120 navigation system for the computed tomography-guided localization of pulmonary ground-glass nodules: a prospective study with historical controls.

BACKGROUND: Conventional computed tomography (CT)--guided pulmonary nodule localization often has unsatisfactory precision and efficiency. The new RC120 navigation system (Shanghai Simple Touch Technology Co., Ltd.) is designed to streamline this process. This study aimed to evaluate the efficacy and safety of the RC120 system for the preoperative localization of ground-glass nodules (GGNs) by comparing a prospectively enrolled cohort operated by a novice to a historical control cohort operated by experts. METHODS: This single-center study included a prospective cohort of 39 patients scheduled to undergo RC120-assisted localization by a single surgeon with no prior experience in CT-guided percutaneous interventions between July 2024 and January 2025. This group was compared to a retrospective control cohort of 138 patients who underwent conventional free-hand localization by two experienced surgeons between November 2021 and October 2023. The primary endpoint was the overall procedural success rate, defined as successful anchor deployment within 10 mm of the target nodule's border. Key secondary endpoints included localization time, radiation dose, number of needle adjustments, and safety. RESULTS: The baseline characteristics were well-balanced between the groups. Despite the RC120 group having a numerically lower success rate compared to the control group, the difference did not reach statistical significance (82.1% vs. 92.8%; P=0.062), with all RC120 anchor deployments remaining clinically adequate for surgical guidance. Although the procedures in the RC120 group were performed by a novice, there were significant improvements in key efficiency metrics as compared to the control group: the median localization time was shorter (15.0 min vs. 20.5 min; P<0.001), the median number of needle adjustments was lower (0 vs. 2; P<0.001), and the median cumulative radiation dose was lower (913.6 mGy·cm vs. 1091.4 mGy·cm; P=0.003). In terms of safety, the RC120 group had a significantly lower rate of hemothorax (2.6% vs. 21.0%; P=0.006). Learning curve analysis of the novice operator showed no significant correlation between case sequence and procedure time (rs=0.072; P=0.66), indicating a rapid acquisition of proficiency. CONCLUSIONS: In this preliminary study, use of the RC120 navigation system by a novice operator appeared feasible for GGN localization and was associated with enhanced procedural efficiency and reduced hemorrhagic complications as compared to historical free-hand techniques. The lack of a significant correlation between procedure time and case sequence suggests a minimal learning phase. These findings should be validated in future large-scale, randomized controlled trials.