What side effects are associated with this type of intervention?

The most common treatments for kidney stones involving fragmentation, such as extracorporeal shock wave lithotripsy (ESWL), can have side effects including bruising and discomfort at the treatment site, blood in the urine, and potential injury to the kidney or surrounding organs. Other treatments like ureteroscopy may cause urinary tract infections, bleeding, and ureteral injury. Overall, while these treatments are generally effective, they can lead to temporary pain and discomfort, and in rare cases, more serious complications.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney stones that focus on stone fragmentation, similar to the Break Wave™ system. Extracorporeal Shock Wave Lithotripsy (SWL) is a widely used and FDA-approved method that uses shock waves to break kidney stones into smaller fragments that can be passed naturally. Additionally, other methods like laser lithotripsy, which uses laser energy to fragment stones, have also been approved. These treatments aim to reduce the size of the stones, making them easier to expel from the urinary tract.

What other types of research exist?

Promising, novel alternatives to the Break Wave™ system for kidney stone treatment in 2024 include piezoelectric extracorporeal shock wave lithotripsy (ESWL) devices such as the Wolf Piezolith and the EDAP LT-01. These devices use ultrasound imaging and piezoelectric crystals to generate shock waves that fragment stones effectively, with high safety profiles and minimal complications.

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Extracorporeal Shock Wave Lithotripsy

Extracorporeal Lithotripsy for Kidney Stones (SOUND Trial)

N/A

Recruiting

Research Sponsored by SonoMotion

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Target stone is indicated for shock wave lithotripsy (SWL) treatment per American Urological Association (AUA) 2016 guidelines

Target stone must be within the upper urinary tract

Must not have

Subject has an acute untreated urinary tract infection or urosepsis

Patients unwilling to comply with the follow-up protocol, including post-procedure radiographic imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 +/- 2 weeks post final break wave procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the Break Wave™ system, which uses sound waves to break up kidney stones. It targets patients with stones between 4mm and 10mm in size. The goal is to see if the device is safe and effective in making the stones small enough to pass naturally. The Break Wave™ system is a new method of lithotripsy that uses short, broadly focused bursts of ultrasound rather than shock waves to fragment stones.

Who is the study for?

This trial is for adults with kidney stones larger than 4mm but smaller or equal to 10mm, located in the upper urinary tract and suitable for shock wave treatment. Participants must be able to give informed consent, follow the study protocol, and attend follow-up visits. Excluded are those under 18, pregnant women, patients on anticoagulants who can't stop them temporarily, individuals with certain aneurysms or solitary kidneys, those unable to understand the consent form, anyone with untreated UTIs or urosepsis, prisoners or vulnerable groups.

What is being tested?

The SOUND Pivotal Trial tests the Break Wave™ system's safety and effectiveness in breaking up kidney stones using extracorporeal lithotripsy. Patients will undergo one procedure followed by a telehealth check-in at two weeks and an imaging study around ten weeks later to assess stone fragmentation.

What are the potential side effects?

Potential side effects of Break Wave extracorporeal lithotripsy may include discomfort at the site of treatment, bruising or bleeding due to shock waves passing through tissue; there could also be risks associated with sedation if used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney stone is suitable for shock wave treatment according to 2016 guidelines.

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My kidney stone is in the upper part of my urinary tract.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an untreated urinary tract infection or urosepsis.

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I am willing to follow all follow-up care instructions, including getting imaging tests.

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My body's structure makes it hard to target kidney stones with sound waves.

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I am younger than 18 years old.

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I have a calcified aneurysm in my abdomen or kidney arteries.

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I have a bleeding or clotting disorder that hasn't been treated.

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I have only one kidney.

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I am on blood thinners and cannot or will not stop them for the procedure.

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I have a blockage in my urinary tract caused by a stone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 +/- 2 weeks post final break wave procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 +/- 2 weeks post final break wave procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 +/- 2 weeks post final break wave procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Primary Effectiveness Endpoint

Primary Safety Endpoint

Secondary study objectives

Secondary safety endpoint

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Break Wave™ ProcedureExperimental Treatment1 Intervention

The subject will undergo the Break Wave procedure.

0 / 11Eligibility 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, such as the Break Wave™ system, use shock waves to fragment stones into smaller pieces that can be passed more easily through the urinary tract. This non-invasive method focuses shock waves on the stone, causing it to break apart. This approach is important for patients as it offers an effective and safer alternative to surgery, leading to quicker recovery and fewer complications.

The effect of rate of shock wave delivery on the efficiency of lithotripsy.