Format

Send to

Choose Destination
J Urol. 2016 Apr;195(4 Pt 1):956-64. doi: 10.1016/j.juro.2015.10.131. Epub 2015 Oct 30.

First in Human Clinical Trial of Ultrasonic Propulsion of Kidney Stones.

Author information

1
Department of Urology, School of Medicine, Seattle, Washington. Electronic address: jdharper@uw.edu.
2
Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington.
3
Department of Urology, School of Medicine, Seattle, Washington.
4
Department of Urology, School of Medicine, Seattle, Washington; Division of Urology, Department of Veteran Affairs Medical Center, Seattle, Washington.
5
Department of Radiology, School of Medicine, Seattle, Washington.
6
Department of Urology, Indiana University School of Medicine, Indianapolis, Indiana.
7
Department of Urology, School of Medicine, Seattle, Washington; Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington.

Abstract

PURPOSE:

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.

MATERIALS AND 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.

KEYWORDS:

kidney calculi; lithotripsy; nephrolithiasis; therapies, investigational; ultrasonography

PMID:
26521719
PMCID:
PMC4851928
DOI:
10.1016/j.juro.2015.10.131
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center