What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for kidney stones, such as extracorporeal shock wave lithotripsy (ESWL), ureteroscopy, and percutaneous nephrolithotomy (PCNL), can have side effects including pain, bleeding, infection, and injury to the urinary tract. Focused ultrasound (ultrasonic propulsion), a newer technology being studied, aims to move stone fragments to facilitate their passage and reduce symptomatic events. While specific side effects of focused ultrasound are still under investigation, it is generally considered less invasive and may have fewer complications compared to traditional methods. However, potential risks could include localized tissue damage and discomfort during the procedure.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments similar to the ultrasonic propulsion method for kidney stones. However, traditional treatments for kidney stones include extracorporeal shockwave lithotripsy (ESWL), which uses shock waves to break stones into smaller fragments that can be passed naturally. Other treatments include medications like alpha-blockers to facilitate stone passage and surgical options such as ureteroscopy and percutaneous nephrolithotomy. The ultrasonic propulsion method being studied aims to move stone fragments to improve their chances of passage, potentially offering a non-invasive alternative to existing treatments.

What other types of research exist?

Promising novel alternatives to Focused Ultrasound for kidney stone treatment in 2024 include: 1) Thulium Laser Lithotripsy, which offers precise stone fragmentation with minimal tissue damage; 2) Holmium Laser Lithotripsy, known for its effectiveness in treating various stone compositions; and 3) Robotic-Assisted Ureteroscopy, which enhances precision and control during stone removal procedures. These methods are gaining traction due to their minimally invasive nature and high success rates.

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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

No Placebo-Only Group

Summary

This trial tests using sound waves to move kidney stones in patients who have leftover fragments after treatment. The goal is to help these stones pass naturally, reducing pain and the need for further treatments. Focused ultrasound has been developed and tested for relocating and expelling kidney stones.

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.

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.

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 weeks3 visits

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).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of low frequency adverse events of interest

Measurement of relapse

Measurement of stone passage

Secondary study objectives

Measurement of all adverse effects associated with the procedure

Other study objectives

Measurement of discomfort related to the procedure

Measurement of stone motion caused by ultrasound

Measurement of the reduction in stone burden based on imaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met

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.