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Project Title:  First Clinical Test of Feasibility of Ultrasound to Reposition Kidney Stones Reduce
Fiscal Year: FY 2015 
Division: Human Research 
Research Discipline/Element:
HRP ExMC:Exploration Medical Capabilities
Start Date: 07/01/2013  
End Date: 12/31/2014  
Task Last Updated: 04/03/2015 
Download report in PDF pdf
Principal Investigator/Affiliation:   Wessells, Hunter B. M.D. / University of Washington 
Address:  Department of Neurology 
1959 NE Pacific Street, Box 356510 
Seattle , WA 98195 
Email: wessells@u.washington.edu 
Phone: 206-543-3640  
Congressional District:
Web:  
Organization Type: UNIVERSITY 
Organization Name: University of Washington 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Bailey, Michael  University of Washington 
Harper, Jonathan David  University of Washington 
Dunmire, Barbrina  University of Washington 
Coburn, Michael  Baylor College of Medicine 
Lingeman, James  Indiana University School of Medicine 
Project Information: Grant/Contract No. NCC 9-58-SMST00002 
Responsible Center: NSBRI 
Grant Monitor:  
Center Contact:   
Solicitation / Funding Source: Directed Research 
Grant/Contract No.: NCC 9-58-SMST00002 
Project Type: GROUND 
Flight Program:  
TechPort: No 
No. of Post Docs:
No. of PhD Candidates:
No. of Master's Candidates:
No. of Bachelor's Candidates:
No. of PhD Degrees:
No. of Master's Degrees:
No. of Bachelor's Degrees:
Human Research Program Elements: (1) ExMC:Exploration Medical Capabilities
Human Research Program Risks: (1) ExMC:Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities (IRP Rev E)
Human Research Program Gaps: (1) ExMC 4.13:We have limited capability to screen for, diagnose, and treat renal stones during exploration missions (IRP Rev E)
Task Description: INTRODUCTION AND OBJECTIVES: Ultrasonic propulsion is a new technology we have developed that uses focused ultrasound energy to transcutaneously reposition kidney stones. On Earth and in space, the use is to expel small stones from the kidney so they will pass naturally before requiring surgery or to prevent large stones in the kidney from obstructing and causing pain or requiring urgent surgery. On Earth, the technology could also be used to expel fragments remaining after surgery that may grow to cause recurrent symptoms. 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 Investigational Review Board and the U.S. FDA through an Investigational Device Exemption. This was an investigator-sponsored study funded by the National Space Biomedical Research Institute (NSBRI) without commercial involvement. 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 56 ± 11 years; average BMI was 29 ± 3; and stone size range was dust to 13 mm. There were 6 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 with the system and repositioned in all but one subject. In total, the system targeted and repositioned stones from all parts of the kidney and ureteropelvic juncture (UPJ, kidney outflow tract) including the lower pole (20 targets), midpole (10 targets), upper pole (6 targets), and renal pelvis/UPJ (7 targets). In two subjects measurable displacement was only seen after pushes as the subjects rolled over on the table. 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 11 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 2 mm fragments immediately after the completion of treatment. Of the two that did not pass stones, one subject felt pain consistent with passing a stone but did not observe stone passage. De novo stones and stones as large as 8 mm were repositioned in awake patients and during URS, although movement was not as great as seen with residual fragments. In four of the 15 subjects, what was noted in clinical imaging as a single, potentially unpassable stone was shown 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. Cost and time from concept to human demonstration were $6M and 5 years.

Research Impact/Earth Benefits: More U.S. citizens have had kidney stones (nephrolithiasis) than have diabetes or heart disease. Direct and indirect costs are estimated at $5B annually. Our stone-moving technology has the potential to cuts risk, costs, and time by preventing surgeries, ER visits, and follow-on x-ray imaging procedures. The product utilizes transcutaneously delivered ultrasound waves to reposition kidney stones. Small stones can be expelled from the kidney preventing surgery and multiple follow-up x-ray exposures. Large stones can be moved deeper into the kidney to alleviate pain and obstruction and avoid emergency surgery. Fragments remaining after surgery can be expelled or repositioned for more effective treatment. With the handheld probe against the patient's skin, the user visualizes the stone and kidney on an ultrasound image, touches the stone image on the touchscreen monitor, and observes that the ultrasound simultaneously moves the stone and maintains real-time imaging. The application to move stones is novel, and our implementation is via novel software on OEM hardware. The technology is non-invasive, doesn't require the patient to be anesthetized and may be used in the urologist's office as well as in the operating room (OR) and emergency room (ER) to provide initial treatment or to supplement surgical treatment. This is the report of the NSBRI-funded, first trial of ultrasound to reposition kidney stones in human subjects.

Task Progress & Bibliography Information FY2015 
Task Progress: 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.

Bibliography Type: Description: (Last Updated: 08/27/2018) 

Show Cumulative Bibliography Listing
 
Abstracts for Journals and Proceedings 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

Abstracts for Journals and Proceedings 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

Abstracts for Journals and Proceedings 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

Abstracts for Journals and Proceedings 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

Abstracts for Journals and Proceedings 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

Articles in Peer-reviewed Journals 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
Awards Dunmire B, Paun M, Cunitz, Wang Y-N, Starr F. "University of Washington Distinguished Staff Award (Team), July 2014." Jul-2014
Awards Harper J. "University of Washington Urology Teaching Award, October 2014." Oct-2014
Awards Bailey M. "Elected to Executive Council of the Acoustical Society of America, October 2014." Oct-2014
Papers from Meeting Proceedings 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

Significant Media Coverage 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
Significant Media Coverage 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
Significant Media Coverage 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
Project Title:  First Clinical Test of Feasibility of Ultrasound to Reposition Kidney Stones Reduce
Fiscal Year: FY 2013 
Division: Human Research 
Research Discipline/Element:
HRP ExMC:Exploration Medical Capabilities
Start Date: 07/01/2013  
End Date: 12/31/2014  
Task Last Updated: 04/01/2015 
Download report in PDF pdf
Principal Investigator/Affiliation:   Wessells, Hunter B. M.D. / University of Washington 
Address:  Department of Neurology 
1959 NE Pacific Street, Box 356510 
Seattle , WA 98195 
Email: wessells@u.washington.edu 
Phone: 206-543-3640  
Congressional District:
Web:  
Organization Type: UNIVERSITY 
Organization Name: University of Washington 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Bailey, Michael  University of Washington 
Harper, Jonathan  University of Washington 
Dunmire, Barbrina  University of Washington 
Coburn, Michael  Baylor College of Medicine 
Lingeman, James  Indiana University School of Medicine 
Project Information: Grant/Contract No. NCC 9-58-SMST00002 
Responsible Center: NSBRI 
Grant Monitor:  
Center Contact:   
Solicitation / Funding Source: Directed Research 
Grant/Contract No.: NCC 9-58-SMST00002 
Project Type: GROUND 
Flight Program:  
TechPort: No 
No. of Post Docs:  
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) ExMC:Exploration Medical Capabilities
Human Research Program Risks: (1) ExMC:Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities (IRP Rev E)
Human Research Program Gaps: (1) ExMC 4.13:We have limited capability to screen for, diagnose, and treat renal stones during exploration missions (IRP Rev E)
Task Description: Kidney stones exert a major burden on the US healthcare system, causing pain, obstruction of the urinary tract, and loss of worker productivity. They are of particular concern in space flight, because microgravity, dehydration, and altered bone metabolism increase the risk of stone development A kidney stone can cause debilitating pain as it passes or worse, become obstructing, and leading to other complications. Thus, developing a non-invasive approach to mitigate against severe complications would be a major advance with potential broad clinical applications on Earth.

Dr. Hunter Wessells and colleagues in the Department of Urology and Applied Physics Laboratory at the University of Washington are conducting a research project to determine whether medical ultrasound devices can be used to reposition kidney stones within the human urinary tract. The research team will assess the safety and feasibility through a pilot clinical trial involving 15 subjects undergoing evaluation and treatment of existing kidney stones. The goal of the study is to determine whether kidney stones can be moved within the kidney and what the patient experiences during the repositioning.

Research Impact/Earth Benefits: One in 11 Americans have had stones. Most form more than one stone over time. Our goal is an office-based procedure to use ultrasound to image and treat these stones and thereby to avoid surgery and repeated x-ray monitoring. Some of the many applications of the novel technology may include relieving obstructing calculi, pre-positioning of stones for improved surgical outcomes, imaging confirmation of stone number and size, and respositioning small kidney stones of residual fragments to facilitate their passage. There is commercial and clinical interest in the technology as it has the potential to change the way stones are treated for many people.

Task Progress & Bibliography Information FY2013 
Task Progress: New project for FY2013.

(Ed. note, 4/1/2015: added to Task Book when received information.)

Bibliography Type: Description: (Last Updated: 08/27/2018) 

Show Cumulative Bibliography Listing
 
 None in FY 2013