Evidence map›Paper›PMID 24975708›Full record

ArticleUrology2014

Preclinical safety and effectiveness studies of ultrasonic propulsion of kidney stones.

Jonathan D Harper, Barbrina Dunmire, Yak-Nam Wang, Julianna C Simon, Denny Liggitt, Marla Paun, Bryan W Cunitz, Frank Starr, Michael R Bailey, Kristina L Penniston and 3 more

Abstract readEvaluation Study
In one paragraph

Article in Urology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Removal of Small, Asymptomatic Kidney Stones and Relapse. Reply.The New England journal of medicine · 2022
    Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Characterizing the Acoustic Output of an Ultrasonic Propulsion Device for Urinary Stones.IEEE transactions on ultrasonics, ferroelectrics, and frequency control · 2017
    Article
  12. Article
  13. Evaluation of Renal Calculi Passage While Riding a Roller Coaster.The Journal of the American Osteopathic Association · 2017
    Article
  14. Article
  15. Article
  16. Urinary Stone Disease: Advancing Knowledge, Patient Care, and Population Health.Clinical journal of the American Society of Nephrology : CJASN · 2016
    Review
  17. Ultrasonic propulsion of kidney stones.Current opinion in urology · 2016
    Review
  18. Non-invasive measurement of the temperature rise in tissue surrounding a kidney stone subjected to ultrasonic propulsion.Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference · 2015
    Article
  19. Ultrasonic propulsion of kidney stones: preliminary results of human feasibility study.IEEE International Ultrasonics Symposium : [proceedings]. IEEE International Ultrasonics Symposium · 2014
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Jonathan D HarperDepartment of Urology, University of Washington School of Medicine, Seattle, WA. Electronic address: jdharper@uw.edu.
Barbrina DunmireCenter for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA.
Yak-Nam WangCenter for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA.
Julianna C SimonCenter for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA.
Denny LiggittDepartment of Comparative Medicine, University of Washington School of Medicine, Seattle, WA.
Marla PaunCenter for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA.
Bryan W CunitzCenter for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA.
Frank StarrCenter for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA.
Michael R BaileyCenter for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA.
Kristina L PennistonDepartment of Urology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
Franklin C LeeDepartment of Urology, University of Washington School of Medicine, Seattle, WA.
Ryan S HsiDepartment of Urology, University of Washington School of Medicine, Seattle, WA.
Mathew D SorensenDepartment of Urology, University of Washington School of Medicine, Seattle, WA; Division of Urology, Department of Veteran Affairs Medical Center, Seattle, WA.

Funding

SWL AND RENAL INJURY AND STONE COMMINUTIONP01DK043881 · NIDDK · UNIVERSITY OF WASHINGTON · PI LIU, ZIYUE · 1994 to 2023
$33.5M
Noninvasive, non-ionizing localization and clearance of kidney stonesR01DK092197 · NIDDK · UNIVERSITY OF WASHINGTON · PI BAILEY, MICHAEL R · 2011 to 2013
$1.6M
NIDDK NIH HHS DK092197NIDDK NIH HHS DK43881NIDDK NIH HHS P01 DK043881NIDDK NIH HHS R01 DK092197
6 · The paper itself

Abstract

objectiveTo provide an update on a research device to ultrasonically reposition kidney stones transcutaneously. This article reports preclinical safety and effectiveness studies, survival data, modifications of the system, and testing in a stone-forming porcine model. These data formed the basis for regulatory approval to test the device in humans. MATERIALS AND

methodsThe ultrasound burst was shortened to 50 ms from previous investigations with 1-s bursts. Focused ultrasound was used to expel 2- to 5-mm calcium oxalate monohydrate stones placed ureteroscopically in 5 pigs. Additionally, de novo stones were imaged and repositioned in a stone-forming porcine model. Acute safety studies were performed targeting 2 kidneys (6 sites) and 3 pancreases (8 sites). Survival studies followed 10 animals for 1 week after simulated treatment. Serum and urine analyses were performed, and tissues were evaluated histologically.

resultsAll ureteroscopically implanted stones (6/6) were repositioned out of the kidney in 14 ± 8 minutes with 13 ± 6 bursts. On average, 3 bursts moved a stone more than 4 mm and collectively accounted for the majority of relocation. Stones (3 mm) were detected and repositioned in the 200-kg stone-forming model. No injury was detected in the acute or survival studies.

conclusionUltrasonic propulsion is safe and effective in the porcine model. Stones were expelled from the kidney. De novo stones formed in a large porcine model were repositioned. No adverse effects were identified with the acute studies directly targeting kidney or pancreatic tissue or during the survival studies indicating no evidence of delayed tissue injury.

Indexed as

Ultrasonic TherapyAnimalsFemaleKidney CalculiSwine

Identifiers

PMID24975708
PMCPMC4304777

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.