title: First in Human Clinical Trial of Ultrasonic Propulsion of Kidney Stones.
abstract: OBJECTIVE
  Ultrasonic propulsion is a new technology using focused ultrasound energy applied transcutaneously to reposition kidney stones. We report what are to our knowledge the findings from the first human investigational trial of ultrasonic propulsion toward the applications of expelling small stones and dislodging large obstructing stones.
  
  
  METHODS
  Subjects underwent ultrasonic propulsion while awake without sedation in clinic, or during ureteroscopy while anesthetized. Ultrasound 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 less than 5 mm and 5 mm or greater. 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 greater than 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 more than 30 fragments passed by 4 of the 6 subjects who had previously undergone a lithotripsy procedure. The largest stone moved was 10 mm. One patient experienced pain relief during treatment of a large stone at the ureteropelvic junction. In 4 subjects a seemingly large stone was determined to be a cluster of small passable stones after they were moved.
  
  
  CONCLUSIONS
  Ultrasonic propulsion was able to successfully reposition stones and facilitate the passage of fragments in humans. No adverse events were associated with the investigational procedure.
authors.affiliation: Department of Urology, School of Medicine, Seattle, Washington. Electronic address: jdharper@uw.edu.
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Harper
authors.affiliation: Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington.
authors.forename: Bryan W
authors.initials: BW
authors.lastname: Cunitz
authors.affiliation: Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington.
authors.forename: Barbrina
authors.initials: B
authors.lastname: Dunmire
authors.affiliation: Department of Urology, School of Medicine, Seattle, Washington.
authors.forename: Franklin C
authors.initials: FC
authors.lastname: Lee
authors.affiliation: Department of Urology, School of Medicine, Seattle, Washington; Division of Urology, Department of Veteran Affairs Medical Center, Seattle, Washington.
authors.forename: Mathew D
authors.initials: MD
authors.lastname: Sorensen
authors.affiliation: Department of Urology, School of Medicine, Seattle, Washington.
authors.forename: Ryan S
authors.initials: RS
authors.lastname: Hsi
authors.affiliation: Department of Radiology, School of Medicine, Seattle, Washington.
authors.forename: Jeff
authors.initials: J
authors.lastname: Thiel
authors.affiliation: Department of Urology, School of Medicine, Seattle, Washington.
authors.forename: Hunter
authors.initials: H
authors.lastname: Wessells
authors.affiliation: Department of Urology, Indiana University School of Medicine, Indianapolis, Indiana.
authors.forename: James E
authors.initials: JE
authors.lastname: Lingeman
authors.affiliation: Department of Urology, School of Medicine, Seattle, Washington; Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Bailey
mesh_terms: D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007669:Kidney Calculi / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D014464:Ultrasonic Therapy
keywords: kidney calculi; lithotripsy; nephrolithiasis; therapies, investigational; ultrasonography