Ultrasound to Facilitate Stone Passage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)
DeviceNovel 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.
Treatment groups
140 Participants
are divided into 4 treatment groupsGroup A: Phase I: Feasibility Treatment groupExperimental treatment 1 intervention
Group B: Phase 2a: Treatment Group of a randomized control trialExperimental treatment 1 intervention
Group C: Phase 2a: Control group of a randomized control trialNo intervention 0 interventions
Group D: Phase 2b: Spinal Cord Injury Feasibility StudyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety - 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-procedure2
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 procedureSecondary outcomes
1
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 procedure2
Effectiveness - % residual stone volume
Residual stone volume relative to the initial stone volume
Time frame
Day of procedure to 4 months posts procedure3
Effectiveness - need for further stone management
Incidence of new healthcare visits for further stone management
Time frame
Day of procedure to 4 months posts procedure4
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 procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
Indiana University
Collaborator
VA Puget Sound Health Care System
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov