Guangdong True Health Medical Technology Development Co., Ltd.

In recent years, robots specifically designed to assist localization have been developed. Nevertheless, limited studies have systematically investigated the integration of these systems into routine clinical practice.

This prospective, single-center, non-inferiority clinical study was conducted on patients with isolated lung nodules measuring less than 20 mm in diameter between June 2024 and December 2024. The primary outcome was the localization success rate, while secondary outcomes included procedural duration, the number of CT scans required for localization, total dose-length product (DLP), first-pass success rate, localization success rate within a single needle adjustment, and the complication rate. The current study is registered with ClinicalTrials.gov.

A total of 100 patients successfully underwent CT-guided manual needle localization or robotic-assisted needle localization, and all subsequently underwent resection of pulmonary nodules via video-assisted thoracoscopic surgery. The operative times were similar between the two groups. However, it is worth noting that the robotic-assisted navigation group demonstrated smaller deviation (median [IQR], 8.00 [6.00, 9.00] vs. 5.72 [3.07, 7.06]; P < 0.001), fewer CT scans required for localization (median [IQR], 1.00 [1.00, 2.00] vs. 1.00 [1.00, 1.00], P < 0.001), higher first-pass success rate (60% vs. 100%, P < 0.001), higher localization success rate within one needle adjustment (80% vs. 100%, P = 0.001), and lower total DLP (median [IQR], 413.50 [332.50, 496.00] vs. 248.63 [198.07, 276.47] mGy*cm; P < 0.001) compared with traditional manual localization group. Additionally, no significant differences were observed between the two groups in terms of reported complications.

The robotic-assisted navigation system demonstrated efficacy comparable to that of manual CT-guided percutaneous needle localization and may represent a novel alternative for isolated lung nodule localization.