Background: To explore the use of an automated needle targeting (ANT) device as an assistive intraoperative navigation modality during PCNL for the treatment of large renal stones, with the aim of reducing surgical durations and radiation exposure.
Methods: This open-label, single-surgeon clinical trial included patients with a diagnosis of renal stones for whom PCNL using the ANT device via the percutaneous access technique was indicated. Ethical approval was obtained from the UMMC ethics review board (Ref. 20118105-6740). The ANT was assembled after an initial motor calibration, and the image calibration was performed using the patient’s fluoroscopic images. Subsequently, the ANT software calculated a bullseye alignment before percutaneous puncture. Accurate renal access was confirmed by the efflux of urine in the Chiba biopsy needle, as well as by imaging with the C-arm intensifier at different angles. The primary endpoints were the time to successful renal access (from ANT set-up to urine efflux) and adverse events.
Results: In all cases, successful renal access was achieved with a single attempt. The mean time to renal access was 6 minutes, 8 seconds. The mean fluoroscopy duration was 101 seconds, with a mean radiation dose of 23.46 mGy. No adverse events were documented.
Conclusion: The ANT device enabled successful, safe and efficient renal access for PCNL in this study. Further research is needed to justify the effectiveness of this device in terms of enabling accurate renal access while reducing the surgical duration and radiation exposure to both surgeons and patients.