Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04796792

Ultrasound to Facilitate Stone Passage

Led by University of Washington · Updated on 2025-12-09

140

Participants Needed

3

Research Sites

291 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

I

Indiana University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Ultrasound to Facilitate Stone Passage

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals presenting with at least one kidney stone
  • Stone size greater than 2 mm and up to 7 mm as shown by clinical imaging
  • Individuals with spinal cord injury (Phase 2b only)
Not Eligible

You will not qualify if you...

  • Individuals under 18 years of age
  • Pregnant individuals or those trying to get pregnant
  • Prisoners
  • Individuals with cognitive impairment limiting understanding of consent or participation
  • Individuals unable to read or understand English
  • Individuals 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 on anticoagulants unwilling or unable to temporarily stop medication for the procedure
  • Individuals with calcified abdominal aortic aneurysm or calcified renal artery aneurysm on the same side as the targeted stone
  • Individuals with a solitary kidney
  • Individuals with an uncorrected urinary tract obstruction
  • Individuals with an untreated infection
  • Individuals with comorbidities making them poor candidates as judged by the physician
  • Individuals who have had two previous investigational procedures for the same stone
  • Individuals who had the investigational procedure within the last 21 days or still have unresolved adverse events from a prior procedure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Indiana University Health - North Hospital

Carmel, Indiana, United States, 46032

Withdrawn

2

VA Puget Sound Health Care System

Seattle, Washington, United States, 98108

Actively Recruiting

3

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

M

Michael Bailey, PhD

CONTACT

B

Barbrina Dunmire, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

4

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Ultrasound to Facilitate Stone Passage | DecenTrialz