Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones

Study Overview
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Brief Summary
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A feasibility study to test the ability to move kidney stones using focused ultrasound. It is the goal of our technology to: a) move stone fragments to a location within the kidney to improve their chances of passage, and thus reduce the occurrence of additional symptomatic events and retreatment or b) move a symptomatic stone to relieve symptoms and pain.

Detailed Description
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Our research group has developed a new, non-invasive technology using low intensity focused ultrasound to reposition kidney stones by imparting sufficient acoustic energy to physically move a stone. The focused ultrasound pulses are similar to pulses that may be used in elastography or acoustic radiation force imaging. Like conventional ultrasound, the probe is placed in contact with the patient's skin to image the stone following standard ultrasound imaging procedure. The same probe is then used to focus the ultrasound and apply a burst (a sequence of pulses) of acoustic force to push the stone. Brightness mode (B-mode) imaging is interleaved with the pushing pulses (Push-mode) to monitor stone movement. The user controls the burst amplitude. For patient safety, there is a slight delay before the operator can execute the next push.

Official Title
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Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones

Conditions
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Kidney Stones, Nephrolithiasis, Urolithiasis

Intervention / Treatment
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* Device: Propulse 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals presenting to the University of Washington (UW) medical system or Veterans Affairs Puget Sound healthcare system with at least one kidney stone or stone fragment that is apparent on kidney-ureter-bladder (KUB) x-ray, computed tomography (CT), or ultrasound imaging. Individuals scheduled for a lithotripsy procedure Individuals presenting to clinic or the emergency department with an acute obstructing stone Primary Exclusion Criteria: Individuals under 18 years of age Individuals with non-echogenic stones Individuals unable or unwilling to comply with the follow-up requirements Individuals with a coagulation abnormality or taking blood thinners or other anticoagulant at clinically significant levels Individuals with mobility issues who are unable to comfortably lie for up to 30 minutes or roll from their back to their side Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.) In addition, there are secondary exclusion criteria for subjects undergoing a symptomatic stone event that are evaluated at the time of the event.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Ultrasonic Propulsion<br>Subjects receive treatment with the Propulse 1 device. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. | Device: Propulse 1<br>* Move kidney stones with Propulse 1 device.<br>|
| No Intervention: Control<br>Subject follow same protocol as treatment group but do not receive the ultrasonic propulsion intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of stone displacement caused by ultrasound | The primary outcome measure is whether the stone moved a distance greater than 2 mm. Measurement is made by positioning calipers on the original stone location and the final stone location on the ultrasound image and measuring the distance between them. | Measurement occurs at the time of treatment and is evaluated with each treatment pulse. The entire procedure, including screening, is expected to last 1 hour with treatment lasting approximately 30 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of discomfort or adverse effects of treatment | The study measures any subject discomfort or adverse response to the device or procedure. The subject will be asked directly what feeling or discomfort, if any, they experienced with each treatment pulse. The subject will be asked to fill out a pain questionnaire before and after the research study. The subject will be contacted for several follow-up phone interviews to assess for adverse events and asked to return for a follow-up imaging examination. | At the time of treatment, weekly for 3 weeks following treatment (5-10 minute phone call), and follow-up imaging 4-6 weeks after treatment requiring about 1 hour of time. | 
| Measurement of direction of movement of the stone | We test the ability to move the stone in a pre-determined direction with device application. | At the time of treatment. To be evaluated with each treatment pulse over a 1 hour study | 
| Measurement of effect of stone size | We will measure if fewer large ( > 5 mm) stones move versus small ( < 5 mm) stones. | The stone size is measured during prescreening. | 
| Reduction in acute stone symptoms | We test the ability to move an acute obstructing stone and relieve the emergent symptoms. The study would be done in clinic or the emergency department after the symptoms have been managed. | Approximately 30 minutes while being evaluated in clinic or in the emergency department. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stones, kidney, stone fragments, lithotripsy