Task Progress:
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Patients presenting to the University of Washington (UW) urology clinic with a documented kidney stone on imaging were screened for this study. Those who met the study criteria and indicated initial willingness to participate to the clinical staff were approached by research staff. The research staff explained the study and obtained informed consent. During the funded year the specific aims were completed and the pilot human study enrolled all 15 approved subjects per protocol.
Investigative Procedures included: a) Prior to the ultrasound study, participants completed a baseline pain questionnaire. b) Participants underwent a diagnostic ultrasound examination by a certified sonographer and Dr. Harper with the investigational device. This verified the stone was visible on ultrasound and near the location identified on the most recent diagnostic imaging. c) A video of the ultrasound exam screen was recorded. Select images of the kidney anatomy and stone were also captured. d) Participants underwent stone pushing with the investigational device. The operator began with 50-V output and increased to 90-V as necessary. Patient feedback on discomfort was recorded after each of the first 3 pushes and when noted otherwise. e) A second video of the ultrasound image from the first frame of the Push to 15 frames after the Push, and listing of the system settings, including the target location and Push power, were recorded automatically to the system hard drive. The patient position, stone position, and result of the Push burst were recorded manually. There were three potential types of motion for each push pulse, 1) no motion, 2) moved but trapped within a confined space, such as a calyx, 3) translation of the stone to a new location. A fourth option was (U) unintended Push. The IDE limited a maximum of 40 push pulses in a single session. f) Participants underwent a second diagnostic ultrasound exam to confirm the location of the stone after treatment. A video of the exam was recorded, and select images of the kidney anatomy and stone were captured. g) Participants completed a second questionnaire at the completion of the exam addressing any discomfort or pain they may have felt related to the procedure. h) Research staff contacted the patients by telephone each week for three weeks and reviewed their charts weekly for 90 days to assess for acute colic events, stone passage, and/or additional intervention. i) Subjects who might pass stones were asked to screen their urine and after 4 weeks received a clinical ultrasound exam to assess location and number of remaining stones. Otherwise in subjects scheduled to undergo surgery following the procedure, ureteroscopy video and notes were saved relating the number, location, size, and tissue attachment of stones.
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Abstracts for Journals and Proceedings
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Harper J, Bailey M. "Novel Use of Ultrasound for Kidney Stone Management. Invited plenary talk." AUA 2015 (American Urological Association), New Orleans, LA, May 15-19, 2015. AUA 2015 (American Urological Association), New Orleans, LA, May 15-19, 2015. , May-2015
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Abstracts for Journals and Proceedings
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Bailey M, Cunitz B, Dunmire B, Harper J, Lee F, Hsi R, Sorensen M, Lingeman J, Karzova, Yuldashev PV, Khokhlova VA, Sapozhnikov OA. "Acoustic radiation force to reposition kidney stones in humans." 169th Meeting of the Acoustical Society of America, Pittsburgh, Pennsylvania, May 18-22, 2015. Journal of the Acoustical Society of America. 2015;137(4):2364. http://dx.doi.org/10.1121/1.4920588 , May-2015
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Abstracts for Journals and Proceedings
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Bailey M, Cunitz B, Dunmire B, Sorensen M, Lee F, Lingeman J, Coburn M, Wessells H, Harper J. " Preliminary Results of the Initial Human Clinical Trial of Focused Ultrasound to Reposition Kidney Stones." 4th International Symposium Focused Ultrasound 2014, Bethesda, MD, October 12-14, 2014. 4th International Symposium Focused Ultrasound 2014, Bethesda, MD, October 12-14, 2014. , Oct-2014
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Abstracts for Journals and Proceedings
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Harper J, Lee F, Cunitz, Dunmire B, Paun M, Ross S, Bailey M, Lingeman J, Coburn M, Wessells H, Sorensen M. "Ultrasonic propulsion of kidney stones: preliminary results from first in human feasibility study. use of ultrasound in stone disease." 32nd World Congress Meeting on Endourology, Taiwan, September 3-7, 2014. Journal of Endourology. 2014 Sep;28(S1):A30. http://dx.doi.org/10.1089/end.2014.3500 (entire program). , Sep-2014
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Abstracts for Journals and Proceedings
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Harper J, Dunmire B, Cunitz B, Lee F, Hsi R, Thiel J, Lingeman J, Coburn M, Wessells H, Sorensen M, Bailey M. " Report on the feasibility of ultrasound to reposition kidney stones in humans." AUA 2015 (American Urological Association), New Orleans, LA, May 15-19, 2015. AUA 2015 (American Urological Association), New Orleans, LA, May 15-19, 2015. http://www.aua2015.org/abstracts/files/presenter_HarperJonathan.cfm ; accessed 5/26/15. , May-2015
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Articles in Peer-reviewed Journals
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Harper JD, Cunitz BW, Dunmire B, Lee FC, Sorensen MD, Hsi RS, Thiel J, Wessells H, Lingeman JE, Bailey MR. "First-in-human clinical trial of ultrasonic propulsion of kidney stones." J Urol. 2016 Apr;195(4 Pt 1):956-64. Epub 2015 Oct 30. http://dx.doi.org/10.1016/j.juro.2015.10.131 ; PubMed PMID: 26521719; PubMed Central PMCID: PMC4851928 , Apr-2016
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Articles in Peer-reviewed Journals
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Hall MK, Thiel J, Dunmire B, Samson PC, Kessler R, Sunaryo P, Sweet RM, Metzler IS, Chang HC, Gunn M, Dighe M, Anderson L, Popchoi C, Managuli R, Cunitz BW, Burke BH, Ding L, Gutierrez B, Liu Z, Sorensen MD, Wessells H, Bailey MR, Harper JD. "First series using ultrasonic propulsion and burst wave lithotripsy to treat ureteral stones." J Urol. 2022 Nov 1;208(5):1075-82. https://pubmed.ncbi.nlm.nih.gov/36205340 ; PMID: 36205340; PMCID: PMC10089227 , Nov-2022
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Awards
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Dunmire B, Paun M, Cunitz, Wang Y-N, Starr F. "University of Washington Distinguished Staff Award (Team), July 2014." Jul-2014
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Awards
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Harper J. "University of Washington Urology Teaching Award, October 2014." Oct-2014
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Awards
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Bailey M. "Elected to Executive Council of the Acoustical Society of America, October 2014." Oct-2014
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Papers from Meeting Proceedings
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Bailey M, Lee F, Cunitz, Dunmire B, Paun M, Ross S, Lingeman J, Coburn M, Wessells H, Sorensen M, Harper J. "Ultrasonic Propulsion of Kidney Stones: Preliminary Results from Human Feasibility Study." 2014 IEEE International Ultrasonics Symposium (IUS), Chicago, IL, September 3-6, 2014. 2014 IEEE International Ultrasonics Symposium (IUS 2014): Proceedings of a meeting held 3-6 September 2014, Chicago, Illinois, USA. Printed by Curran Associates, Inc. http://dx.doi.org/10.1109/ULTSYM.2014.0126 , Dec-2014
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Significant Media Coverage
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Krader CK. "Article in Urology Times, 'Ultrasound stone repositioning found safe, effective: Technique shows both therapeutic and diagnostic potential.' Description of PI team's research with interviews." Urology Times, November 25, 2014. http://urologytimes.modernmedicine.com/urology-times/news/ultrasound-stone-repositioning-found-safe-effective ; accessed 5/26/15., Nov-2014
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Significant Media Coverage
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Yard DH. "Ultrasonic Propulsion of Kidney Stones: Interview with Jonathan Harper, MD. May 12, 2014." Renal & Urology News. Expert Q and A series. August 2014 issue. http://www.renalandurologynews.com/expert-qa/ultrasonic-propulsion-of-kidney-stones-interview-with-jonathan-harper-md/article/346605/ ; accessed 5/26/15., Aug-2014
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Significant Media Coverage
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Collins M. "Preview article about Plenary II State-of-the-Art Lecture by Jonathan Harper." AUA (American Urological Association) Daily News, AUA Annual Meeting newspaper. May 2015., May-2015
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