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Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 J+Urol 2016 ; 195 (4 Pt 1): 956-64 Nephropedia Template TP
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First-in-human clinical trial of ultrasonic propulsion of kidney stones #MMPMID26521719
J Urol 2016[Apr]; 195 (4 Pt 1): 956-64 PMID26521719show ga
Purpose: Ultrasonic propulsion is a new technology using focused ultrasound energy applied transcutaneously to reposition kidney stones. We report the findings from the first human investigational trial of ultrasonic propulsion toward the applications of expelling small stones and dislodging large obstructing stones. Materials and Methods: Subjects underwent ultrasonic propulsion either awake without sedation in clinic or during ureteroscopy while anesthetized. Ultrasound imaging and a pain questionnaire were completed before, during, and after propulsion.The primary outcome was to reposition stones in the collecting system. Secondary outcomes included safety, controllable movement of stones, and movement of stones < 5 mm and ? 5 mm. Adverse events were assessed weekly for 3 weeks. Results: Kidney stones were repositioned in 14 of 15 subjects. Of the 43 targets, 28 (65%) showed some level of movement while 13 (30%) were displaced > 3 mm to a new location. Discomfort during the procedure was rare, mild, brief, and self-limited. Stones were moved in a controlled direction with over 30 fragments being passed by 4 of 6 subjects who previously had a lithotripsy procedure. The largest stone moved was 10 mm. One patient experienced pain relief during treatment of a large stone at the UPJ. In 4 subjects a seemingly large stone was determined to be a cluster of small passable stones once moved. Conclusions: Ultrasonic propulsion was able to successfully reposition stones and facilitate passage of fragments in humans with no adverse events associated with the investigational procedure.