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.
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 has completed Phase 1. The study is currently recruiting for Phase 2b. Recruitment has not yet started for Phase 2a. 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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.
Indiana University Health - North Hospital
Carmel, Indiana, United States
WITHDRAWNVA Puget Sound Health Care System
Seattle, Washington, United States
RECRUITINGUniversity of Washington
Seattle, Washington, United States
RECRUITINGSafety - incidence of return healthcare visits.
Incidence of return health care visits associated with the device or procedure.
Time frame: 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.
Time frame: Day of procedure to 4 months posts procedure
Safety - incidence of adverse events (AEs)
The incidence of all adverse events (AEs) associated with the device or procedure
Time frame: Day of procedure to 4 months posts procedure
Effectiveness - % residual stone volume
Residual stone volume relative to the initial stone volume
Time frame: Day of procedure to 4 months posts procedure
Effectiveness - need for further stone management
Incidence of new healthcare visits for further stone management
Time frame: 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/.
Time frame: Day of procedure to 14 months posts procedure
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