A Prospective, Multicenter, Single-Arm Study to Evaluate the Efficacy and Safety of Augmented Reality Navigation-Guided Pulmonary Nodule Localization System

OBJECTIVES: With the popularization and wide acceptance of low-dose computed tomography lung cancer screening, an increasing number of lung cancers are found in the form of small pulmonary nodules (SPNs). Accurate, rapid, and safe localization of SPNs is crucial for their surgical resection. This study aims to evaluate the efficacy and safety of an augmented reality (AR) navigation-guided pulmonary nodule (PN) localization system. METHODS: This is a prospective, multicentre, single-arm objective performance criteria clinical trial. The puncture navigation software and PN localization system were employed in the operating room for preoperative localization of SPNs, and subsequent resection was performed by video-assisted thoracic surgery (VATS). The primary end point was the localization success, and the secondary end points included localization time, distance from nodule to localizer, device performance evaluation, and localization-related complication as a safety end point. RESULTS: A total of 106 patients underwent PN localization and VATS resection. Localization success was achieved in 101 patients at a rate of 95.28% (95% CI (confidence interval), 91.25%-99.32%), reaching the objective performance criteria of 91%. The median localization time was 3.1 min (range: 1.0-22.0 min). The median distance from nodule to localizer was 5 mm (range: 1-9 mm). In 104 (98.11%) patients, software recognition, post-processing software fluency, and post-processing software prompt accuracy were excellent. No localization-related complication was observed. CONCLUSIONS: The newly developed AR navigation-guided PN localization system is effective and safe in facilitating the localization of SPNs. CLINICAL REGISTRATION NUMBER: This study was registered with the Chinese Clinical Trial Registry (ChiCTR2200055612).