PD42-01 REPORT ON THE FEASIBILITY OF ULTRASOUND TO REPOSITION KIDNEY STONES IN HUMANS

Abstract

You have accessJournal of UrologyStone Disease: New Technology1 Apr 2015PD42-01 REPORT ON THE FEASIBILITY OF ULTRASOUND TO REPOSITION KIDNEY STONES IN HUMANS Jonathan Harper, Barbrina Dunmire, Bryan Cunitz, Franklin Lee, Ryan Hsi, Jeff Thiel, James Lingeman, Michael Coburn, Hunter Wessells, Mathew Sorensen, and Michael Bailey Jonathan HarperJonathan Harper More articles by this author , Barbrina DunmireBarbrina Dunmire More articles by this author , Bryan CunitzBryan Cunitz More articles by this author , Franklin LeeFranklin Lee More articles by this author , Ryan HsiRyan Hsi More articles by this author , Jeff ThielJeff Thiel More articles by this author , James LingemanJames Lingeman More articles by this author , Michael CoburnMichael Coburn More articles by this author , Hunter WessellsHunter Wessells More articles by this author , Mathew SorensenMathew Sorensen More articles by this author , and Michael BaileyMichael Bailey More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2586AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Ultrasonic propulsion is a new technology we have developed which uses focused ultrasound energy to transcutaneously reposition kidney stones. Safety and effectiveness has been demonstrated in a porcine model. We report the findings from the first use of this technology in humans. METHODS Studies were conducted with the approval of the University of Washington IRB and FDA Investigational Device Exemption. Thirteen awake, non-anesthetized subjects were studied without restriction of patient body habitus, stone size, or stone location. Ultrasound imaging and a pain questionnaire were completed before, during, and following propulsion. An additional two subjects underwent stone repositioning during ureteroscopy (URS). All subjects were followed weekly for three weeks. RESULTS Of the 15 subjects, 11 were male, average age was 55+/- 9 years, BMI 28.5 +/- 2.7, and stone size 1-13 mm. There were 5 left and 10 right kidneys treated. Two patients reported skin discomfort and sensation at depth with a few pushes. Otherwise, there was no pain or adverse effects associated with the treatment. Stones were localized and some degree of movement was seen in all but one subject. Stone locations included the lower pole (>20), interpolar (>10), upper pole (>5), and renal pelvis/UPJ (>5). Average skin-to-stone distance was 6.5 cm, as the probe was small enough to push under the ribs with subjects on their side; although when this was not possible, such as during URS, stones were imaged and repositioned at depths greater than 12 cm. Stones were repositioned to a new location in all 6 post-lithotripsy patients, while 4 of the 6 passed over 30 stone fragments within a few days of treatment. One passed two 2mm fragments immediately after the completion of treatment. One of the 6 felt pain consistent with passing a stone, but did not observe stone passage. The sixth subject was lost to follow-up. De novo stones were less often moved to a new location. Stones as large as 7-8 mm were repositioned in awake patients and during URS. In four of the 15 subjects, what was noted in clinical imaging as a single stone greater than 5 mm was found to be several passable stones upon repositioning with ultrasound. CONCLUSIONS Ultrasonic propulsion can safely and without pain reposition kidney stones in humans. Treatment was therapeutic in four subjects and provided diagnostic information in four. Overall, the initial clinical trial was successful and warrants continued research and development. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e885 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jonathan Harper More articles by this author Barbrina Dunmire More articles by this author Bryan Cunitz More articles by this author Franklin Lee More articles by this author Ryan Hsi More articles by this author Jeff Thiel More articles by this author James Lingeman More articles by this author Michael Coburn More articles by this author Hunter Wessells More articles by this author Mathew Sorensen More articles by this author Michael Bailey More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...