Harper JD, Metzler I, Hall MK, Chen TT, Maxwell AD, Cunitz BW, Dunmire B, Thiel J, Williams JC Jr, Bailey MR, Sorensen MDJ.
J Endourol. 2020 Sep 17. doi: 10.1089/end.2020.0725
Abstract
Purpose: To test the effectiveness (Participant A) and tolerability (Participant B) of urinary stone comminution in the first-in-human trial of a new technology, burst-wave lithotripsy (BWL), Materials and Methods: An investigational BWL and ultrasonic propulsion system was used to target a 7-mm kidney stone in the operating room prior to ureteroscopy (Participant A). The same system was used to target a 7.5 mm ureterovesical junction (UVJ) stone in clinic without anesthesia (Participant B).
Results: For Participant A, a ureteroscope inserted following 9 minutes of BWL observed fragmentation of the stone to <2 mm fragments. Participant B tolerated the procedure without pain from BWL, required no anesthesia, and passed the stone on day 15.
Conclusions: The first-in-human tests of BWL pulses were successful in that a renal stone was comminuted in under 10 minutes, and BWL was also tolerated by an awake subject for a distal ureteral stone.
During recent years we had followed the technical achievements with burst wave lithotripsy (BWL) and it is now of great interest and importance to learn that the method also works clinically.
The principle of BWL is to disintegrate stones with a “dusting” approach by application of sinusoidal bursts of ultrasound. In addition to stone disintegration BWL has propulsive properties so that fragments can be repositioned within the calyceal system and eliminated via the ureter.
The device is composed of two parts: one hand-held probe for BWL and another one for ultrasound propulsion.
Two patients were included in this preliminary study, one given anesthesia and the other not.
One 7 mm stone was successfully disintegrated into fragments