Login to Access Video or Poster Abstract: MP50-09
Sources of Funding: The study was funded by Auris Surgical Robotics.

Introduction

To present the first in man experience with the Robotic Endoscopy System (RES) for the treatment of renal and ureteral calculi.

Methods

The RES is a novel system comprised of a remote-driven robotic flexible ureteroscope and robotic access sheath. The robotic ureteroscope incorporates digital optics and the system has the ability to control the laser fiber and irrigation inflow-outflow remotely. The system has a stroke length to navigate the collecting system from the urethra to the kidney. The primary performance endpoint was completion of the intended procedure; the primary safety endpoint was incidence of perioperative complication. The RES performance was graded on a visual analog scale of 1 (worst) to 10 (best) for stability, ease of locating stones, ability to fragment, control and visualization. P values were calculated using the Mann-Whitney U test or Fisher's exact test.

Results

Of 18 screened adult patients, 16 underwent flexible robotic ureteroscopy (11 with 1; 4 with 2 and 1 with 3 stones). Two patients were excluded intraoperatively due to ureteral strictures. The twenty-two treated stones were distributed throughout the collecting system (n = 7 lower pole, n = 5 renal pelvis, n = 5 interpolar, n = 3 upper ureter, n = 1 upper pole and n = 1 distal ureter). Median stone size was 10 (6 to 20) mm. All procedures were completed successfully using robotic control. One patient experienced fever (101 °F) that resolved without intervention. Overall, median total procedure time (TPT) was 73.5 (range = 21 to 131) minutes; median total robot time (TRT) was 42 (6 to 99) minutes. In patients with a single stone only, median TPT decreased from 98 (50 to 131) minutes (first 5 cases) to 40 (21 to 77) minutes (last 6 cases), P = 0.036; median TRT also decreased from 44 (20 to 89) minutes (first 5 cases) to 19.5 (6 to 43) minutes (last 6 cases), P = 0.055. In 5 patients with lower pole stones, median TPT was 50 (21 to 131) minutes; median TRT was 20 (16 to 76) minutes. Stability, ease of locating stone and control, as evaluated by number of scores greater than 9, improved significantly in the last 6 cases(P = 0.035).

Conclusions

The robotic ureteroscopy with calculi lithotripsy is safe and feasible using the RES. Future comparative studies to manual ureteroscopy are warranted.

Funding

The study was funded by Auris Surgical Robotics.