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Ultrasound

Ultrasonic Stone Propulsion for Kidney Stones

N/A
Waitlist Available
Led By Jonathan Harper, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Individuals under 18 years of age
Individuals with a coagulation abnormality or taking blood thinners or other anticoagulant at clinically significant levels
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurement over 3-year follow-up (phone call or email encounter semi-annually) and 5-year review of the subject's medical records, including imaging (no subject participation).
Awards & highlights

Summary

This trial is testing whether a new technology can help people pass kidney stones or relieve pain from them.

Who is the study for?
This trial is for adults with visible kidney stones who are part of the UW medical system or Veterans Affairs Puget Sound healthcare system. It's suitable for those scheduled for lithotripsy or with an acute obstructing stone. Excluded are minors, people with non-echogenic stones, those not following up, on significant blood thinners, with mobility issues, or in vulnerable groups.Check my eligibility
What is being tested?
The study tests 'Propulse 1', a focused ultrasound technology designed to move kidney stones within the body. The aim is to either help pass stone fragments more easily or relieve pain by repositioning symptomatic stones.See study design
What are the potential side effects?
While specific side effects aren't listed here, ultrasound propulsion may cause discomfort at the site of application and potential shifts in stone position could lead to temporary increases in pain or obstruction.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I am on blood thinners or have a clotting disorder.
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I cannot lie still for 30 minutes or roll from back to side easily.
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I have undergone four ultrasonic propulsion procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurement over 3-year follow-up (phone call or email encounter semi-annually) and 5-year review of the subject's medical records, including imaging (no subject participation).
This trial's timeline: 3 weeks for screening, Varies for treatment, and measurement over 3-year follow-up (phone call or email encounter semi-annually) and 5-year review of the subject's medical records, including imaging (no subject participation). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measurement of low frequency adverse events of interest
Measurement of relapse
Measurement of stone passage
Secondary outcome measures
Measurement of all adverse effects associated with the procedure
Other outcome measures
Measurement of discomfort related to the procedure
Measurement of stone motion caused by ultrasound
Measurement of the reduction in stone burden based on imaging

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment with Ultrasonic PropulsionExperimental Treatment1 Intervention
Subjects receive treatment with the Propulse 1 device. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter.
Group II: ControlActive Control1 Intervention
Subject follow same protocol as treatment group but do not receive the ultrasonic propulsion intervention.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for kidney stones include shock wave lithotripsy (SWL), ureteroscopy, and percutaneous nephrolithotomy. SWL uses high-energy sound waves to break stones into smaller fragments that can be passed naturally. Ureteroscopy involves using a thin scope to locate and remove or break up stones. Percutaneous nephrolithotomy is a surgical procedure to remove large stones directly from the kidney. Focused ultrasound (ultrasonic propulsion) is a newer, non-invasive technique that uses ultrasound waves to move stones to a location within the kidney that facilitates their natural passage, potentially reducing pain and the need for further interventions. These treatments are crucial as they aim to alleviate symptoms, prevent complications, and reduce the recurrence of kidney stones.
Metabolic risk-evaluation and prevention of recurrence in stone disease: does it make sense?New concepts in shock wave lithotripsy.

Find a Location

Who is running the clinical trial?

VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
227,729 Total Patients Enrolled
University of WashingtonLead Sponsor
1,762 Previous Clinical Trials
1,876,398 Total Patients Enrolled
4 Trials studying Kidney Stones
3,849 Patients Enrolled for Kidney Stones
Jonathan Harper, MDPrincipal Investigator - University of Washington
University of Washington Medical Center
University Of Oklahoma College Of Medicine (Medical School)
Loma Linda University Medical Center (Residency)
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Propulse 1 (Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT02028559 — N/A
Kidney Stones Research Study Groups: Control, Treatment with Ultrasonic Propulsion
Kidney Stones Clinical Trial 2023: Propulse 1 Highlights & Side Effects. Trial Name: NCT02028559 — N/A
Propulse 1 (Ultrasound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02028559 — N/A
~7 spots leftby Jul 2025