Ultrasound Therapy for Kidney Stones
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
If you are taking blood thinners (anticoagulants), you will need to temporarily stop them for the procedure. For other medications, the trial protocol does not specify any requirements.
Is ultrasound therapy for kidney stones safe for humans?
Ultrasound therapy for kidney stones, including techniques like ultrasonic propulsion and burst wave lithotripsy, has been shown to be safe in humans and animal studies. No serious or unexpected side effects were reported, and any discomfort was similar to the normal experience of passing a stone.12345
How is the treatment for kidney stones using Break Wave Lithotripsy and Ultrasonic Propulsion different from other treatments?
What data supports the effectiveness of the treatment Break Wave Lithotripsy, Ultrasonic Propulsion for kidney stones?
Research shows that using ultrasonic propulsion can successfully move kidney stones in humans, with 94% of cases showing significant movement. Additionally, burst wave lithotripsy has been effective in breaking stones in animal models, with all tested stones being fragmented without causing harm.23678
Who Is on the Research Team?
Jonathan Harper, MD
Principal Investigator
University of Washington
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
20 subjects undergo ultrasound treatment to demonstrate initial feasibility
Phase 2a Treatment
100 subjects in a two-arm randomized control trial (RCT) to test ultrasound treatment
Phase 2b Treatment
20 subjects with spinal cord injury undergo ultrasound treatment to demonstrate feasibility
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Break Wave Lithotripsy
- Ultrasonic Propulsion
Find a Clinic Near You
Who Is Running the Clinical Trial?
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