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

Authors
  • Harper, Jonathan D1
  • Metzler, Ian1
  • Hall, Michael Kennedy2
  • Chen, Tony T1
  • Maxwell, Adam D1, 3
  • Cunitz, Bryan W3
  • Dunmire, Barbrina3
  • Thiel, Jeff3
  • Williams, James C4
  • Bailey, Michael R1, 3
  • Sorensen, Mathew D1, 5
  • 1 Department of Urology and University of Washington School of Medicine, Seattle, Washington, USA.
  • 2 Department of Emergency Medicine, University of Washington School of Medicine, Seattle, Washington, USA.
  • 3 Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington, USA.
  • 4 Department of Anatomy, Cell Biology & Physiology, Indiana University School of Medicine, Indianapolis, Indiana, USA. , (India)
  • 5 Division of Urology, VA Puget Sound Health Care System, Seattle, Washington, USA.
Type
Published Article
Journal
Journal of Endourology
Publisher
Mary Ann Liebert
Publication Date
Apr 01, 2021
Volume
35
Issue
4
Pages
506–511
Identifiers
DOI: 10.1089/end.2020.0725
PMID: 32940089
Source
Medline
Keywords
Language
English
License
Unknown

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 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.

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