Assessing the efficacy and safety of a novel, registration-free, CT-guided percutaneous transthoracic needle biopsy navigation system (RC120): A multicenter, prospective, single-arm clinical trial.

197 Background: Current optical and electromagnetic navigation systems for CT-guided percutaneous transthoracic needle biopsies (PTNB) have limitations. They require surface markers on the patient and intraoperative registration. Specific patient positioning during biopsies is required. Our team developed a new navigation system that addresses these issues. It doesn’t rely on patient surface markers or intraoperative registration, and it provides more flexibility in patient positioning during biopsies. Our research evaluates the effectiveness and safety of this system. Methods: A single-arm prospective study was conducted, including participants aged 18-80 years prepared for percutaneous lung core biopsy at two clinical centers in China. The primary endpoint was the success rate of biopsies within 2 needle adjustments. The secondary endpoint was the success rate of biopsies within a single needle adjustment. Safety endpoints were defined by the occurrence of adverse events. The number of CT scans patients underwent during the procedure was used to assess radiation dosage. Follow-up was conducted on subsequent pathological and molecular diagnoses. Results: The study included 98 patients from two sites, with a median age of 64 years. Most participants were males, accounting for 72.45% (71 out of 98). The primary endpoint was achieved with a biopsy success rate of 98.98%, requiring a maximum of two needle adjustments. The secondary endpoint was met, demonstrating a biopsy success rate of 97.96% with a maximum of one needle adjustment. The overall success rate was 98.98%, with a 95% confidence interval (CI) of 94.45% to 99.97%, significantly exceeding the target value of 85% (P < 0.0001). The median number of CT scans was 3, ranging from 3 to 12. The average duration of the procedure was 18.0 minutes. Regarding safety endpoints, the two most common adverse events were hemorrhage in the lesion (14 instances, 29.17%) and pneumothorax (8 instances, 16.67%). Other adverse events included elevated blood pressure (5 instances, 10.42%), hemoptysis (4 instances, 8.33%), and other common adverse events such as cough, constipation, anemia, and bloody sputum, each occurring twice. There were 9 other less common adverse events, each occurring once. These adverse events are common in PTNB and can be attributed to the puncture operation itself, not our navigation system. Conclusions: Our new registration-free navigation system proved to be an effective, efficient, safe, and well-utilized system for assisting percutaneous lung biopsies in clinical practice. Clinical trial information: ChiCTR2300072197 .