First In-Human Burst Wave Lithotripsy for Kidney Stone Comminution: Initial Two Case Studies

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). An investigational BWL and ultrasonic propulsion system was used to target a 7-mm kidney stone in the operating room...

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Published inJournal of endourology Vol. 35; no. 4; p. 506
Main Authors Harper, Jonathan D, Metzler, Ian, Hall, Michael Kennedy, Chen, Tony T, Maxwell, Adam D, Cunitz, Bryan W, Dunmire, Barbrina, Thiel, Jeff, Williams, James C, Bailey, Michael R, Sorensen, Mathew D
Format Journal Article
LanguageEnglish
Published United States 01.04.2021
Subjects
Humans
Kidney Calculi - surgery
Lithotripsy
Ureteral Calculi - surgery
Ureteroscopy
Urinary Calculi - therapy
burst wave lithotripsy
calculi
shock wave lithotripsy
physics
urolithiasis
lithotripsy
ultrasound
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Summary: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). An investigational BWL and ultrasonic propulsion system was used to target a 7-mm kidney stone in the operating room before ureteroscopy (Participant A). The same system was used to target a 7.5 mm ureterovesical junction stone in clinic without anesthesia (Participant B). For Participant A, a ureteroscope inserted after 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. The first-in-human tests of BWL pulses were successful in that a renal stone was comminuted in <10 minutes, and BWL was also tolerated by an awake subject for a distal ureteral stone. Clinical Trial NCT03873259 and NCT02028559.
ISSN:1557-900X
DOI:10.1089/end.2020.0725