Trial Summary
What is the purpose of this trial?This trial tests a new way to help people pass kidney stones using sound waves to break and move the stones. It targets patients with kidney stones, including those with spinal cord injuries. The sound waves break the stones into smaller pieces and help move them so they can pass more easily. Focused ultrasound has been developed to successfully relocate and fragment kidney stones, showing its effectiveness in expelling small stone fragments.
Eligibility Criteria
This trial is for adults with kidney stones larger than 2mm but smaller or equal to 7mm. It's not for those with untreated infections, bleeding disorders, on anticoagulants they can't stop, certain aneurysms, a single kidney, urinary blockages, high comorbidity risks or cognitive impairments. Pregnant individuals and prisoners are excluded.Inclusion Criteria
I have had at least one kidney stone.
People with spinal cord injury (Phase 2b only)
You have a kidney stone that is bigger than 2 millimeters and smaller than or equal to 7 millimeters, as seen in medical images.
Exclusion Criteria
I am on blood thinners and cannot or will not stop them for a study procedure.
I understand my role in giving consent and participating.
I have a calcified aneurysm near my kidney stone.
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Participant Groups
The study tests if ultrasound can help pass kidney stones without anesthesia by breaking them up (Break Wave Lithotripsy) and repositioning them (Ultrasonic Propulsion). This multi-center research does not involve blinding participants to the treatment.
1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
This study is currently in Phase 1 where all subjects undergo the investigational study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WashingtonSeattle, WA
Indiana University Health - North HospitalCarmel, IN
VA Puget Sound Health Care SystemSeattle, WA
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
Indiana UniversityCollaborator
VA Puget Sound Health Care SystemCollaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator