Ultrasound to Facilitate Stone Passage

Study Overview
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Brief Summary
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This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.

Detailed Description
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This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia. Subjects will be included across three phases: Phase 1: 20 subjects to demonstrate initial feasibility Phase 2a: 100 subjects for a two-arm (50:50) randomized control trial (RCT) Phase 2b: 20 subjects to demonstrate feasibility in individuals with spinal cord injury (SCI) This study is currently in Phase 1. Phase 2a and 2b are intended to be conducted in parallel and will not be initiated until after review of the Phase 1 results and approval to proceed to Phase 2 by the FDA. Up to 3 distinct targets may be treated per subject. The maximum total dose exposure is 30 minutes for one session. Subjects may return after at least 21 days and after all AEs have resolved for an additional session on the same side. Subjects may return after imaging follow-up for inclusion of their contralateral side.

Official Title
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Ultrasound Technology to Fragment and Reposition Urinary Stones

Conditions
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Urinary Stone, Urinary Calculi

Intervention / Treatment
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* Device: Break Wave Lithotripsy and Ultrasonic Propulsion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals presenting with at least one kidney stone Stone with maximum dimension > 2 mm and ≤ 7 mm as determined by clinical imaging Individuals with SCI - (Phase 2b only) Exclusion Criteria: Individuals under 18 years of age Individuals who are pregnant or who are trying to get pregnant Prisoners with cognitive impairment that would limit their ability to comprehend their role in consent or participation. Individuals who are unable to read or understand English Individuals who are unable or unwilling to participate in follow up activities Individuals who cannot be positioned for ultrasound imaging Individuals with uncorrected bleeding disorders or coagulopathies Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure Individuals with a solitary kidney Individuals with an uncorrected urinary tract obstruction Individuals with an untreated infection Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure Individuals who have received two previous investigational procedures for the same stone target Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>This study is currently in Phase 1 where all subjects undergo the investigational study. | Device: Break Wave Lithotripsy and Ultrasonic Propulsion<br>* Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - incidence of return healthcare visits. | Incidence of return health care visits associated with the device or procedure. | Day of procedure to 14 months post-procedure | 
| Effectiveness - stone comminution into fragments 2 mm or less. | Number of cases where the largest dimension of any residual stone in the study kidney is less than or equal to 2 mm. | Day of procedure to 4 months posts procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - incidence of adverse events (AEs) | The incidence of all adverse events (AEs) associated with the device or procedure | Day of procedure to 4 months posts procedure | 
| Effectiveness - % residual stone volume | Residual stone volume relative to the initial stone volume | Day of procedure to 4 months posts procedure | 
| Effectiveness - need for further stone management | Incidence of new healthcare visits for further stone management | Day of procedure to 4 months posts procedure | 
| Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire | Quality of life, evaluated by the comparison of Wisconsin Stone Quality of Life (WISQOL) questionnaire scores before and after the investigational procedure. The questionnaire consists of a series of questions to evaluate the symptomatic and functional impact of the stones on a scale of 1 to 5, where a lower score indicates a greater impact. https://urology.wisc.edu/research/wisqol/. | Day of procedure to 14 months posts procedure |