Ultrasound to Facilitate Stone Passage

Not Applicable

Not yet recruiting

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Treatment group	Break Wave Lithotripsy and Ultrasonic Propulsion	This study is currently in Phase 1 where all subjects undergo the investigational study.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety - incidence of adverse events (AEs)	Day of procedure to 4 months posts procedure	The incidence of all adverse events (AEs) associated with the device or procedure
Effectiveness - % residual stone volume	Day of procedure to 4 months posts procedure	Residual stone volume relative to the initial stone volume
Effectiveness - need for further stone management	Day of procedure to 4 months posts procedure	Incidence of new healthcare visits for further stone management
Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire	Day of procedure to 14 months posts procedure	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/.

Locations (3): University of Washington
🇺🇸
Seattle, Washington, United States
Indiana University Health - North Hospital
🇺🇸
Carmel, Indiana, United States
VA Puget Sound Health Care System
🇺🇸
Seattle, Washington, United States