Open AccessFirst In-Human Burst Wave Lithotripsy for Kidney Stone Comminution: Initial Two Case Studies
Author(s) -
Jonathan D. Harper,
Ian Metzler,
M. Kennedy Hall,
Tony T. Chen,
Adam D. Maxwell,
Bryan W. Cunitz,
Barbrina Dunmire,
Jeff Thiel,
James C. Williams,
Michael R. Bailey,
Mathew D. Sorensen
Publication year - 2021
Publication title -
journal of endourology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.121
H-Index - 92
eISSN - 1557-900X
pISSN - 0892-7790
DOI - 10.1089/end.2020.0725
Subject(s) - medicine , lithotripsy , comminution , tolerability , ureteroscopy , kidney stones , urology , surgery , ureter , adverse effect , chemistry
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 before ureteroscopy (Participant A). The same system was used to target a 7.5 mm ureterovesical junction stone in clinic without anesthesia (Participant B). Results: 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. Conclusions: 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.