Status:
RECRUITING
Ultrasound to Facilitate Stone Passage
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Indiana University
VA Puget Sound Health Care System
Conditions:
Urinary Stone
Urinary Calculi
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04796792
Start Date
April 1 2023
End Date
October 31 2028
Last Update
December 9 2025
Active Locations (3)
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1
Indiana University Health - North Hospital
Carmel, Indiana, United States, 46032
2
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
3
University of Washington
Seattle, Washington, United States, 98195