A handheld ultrasound device called the Break Wave lithotripsy system shattered kidney stones in 70% of patients during the SOUND trial, according to results presented at a Washington conference. The device uses low-pressure ultrasound waves to break stones into tiny pieces that pass naturally. Unlike traditional lithotripsy, which uses high-energy shock waves and can harm nearby tissue, this method delivers gentler pulses that target only the stone. Researchers say it’s the first time an in-office procedure like this has shown such high success rates with no side effects reported.

How the Break Wave device works

The Break Wave system sits on the skin over the kidney and delivers controlled ultrasound pulses through a handheld probe. The waves create micro-vibrations that crack the stone without heat or radiation. Patients feel a mild tapping sensation but no pain, according to early user reports. Most treatments take 15 to 30 minutes, and patients walk out the same day. Doctors can adjust the frequency and intensity in real time to match the stone’s size and location.

Trial leaders say the device works best on small to medium stones under 15 millimeters. It struggled with larger stones over 20 millimeters, which required multiple sessions or a different approach. Still, the 70% success rate for breaking stones puts it ahead of some older methods. Traditional shock wave lithotripsy, which uses X-rays to pinpoint stones, only succeeds about 50% of the time in similar cases.

Why it matters for patients

Kidney stones affect about 1 in 10 people at some point, and the pain can be excruciating. Current treatments include shock wave lithotripsy, surgery, or waiting for stones to pass—each with drawbacks. Shock wave therapy can bruise organs or leave fragments behind. Surgery works but requires anesthesia and recovery time. Passing stones naturally is slow and agonizing for many. This new ultrasound method could cut down on repeat procedures and side effects.

The SOUND trial involved 120 patients across three hospitals. Half received the ultrasound treatment, while the other half got standard care. After one session, 70% of the ultrasound group had fully broken stones, compared to 30% in the control group. No one in the trial needed emergency care or reported lasting pain after treatment. Researchers plan to expand the trial to 300 patients next year to confirm the results.

What’s next for ultrasound stone treatment

The Break Wave device is still experimental and not yet approved by the FDA. Its makers say they’re filing for clearance in early 2025. If approved, it could become the go-to option for small kidney stones, cutting healthcare costs and reducing patient suffering. Doctors could use it as a first-line treatment before resorting to surgery or stronger drugs. The device costs about $50,000 per unit, but insurers might cover it if it proves reliable.

For now, patients with kidney stones have one more option to consider. It’s not a cure-all—big stones still need other methods—but it’s a promising step toward gentler, faster care. The next few years will tell if this ultrasound approach becomes standard in clinics across the U.S.

What You Need to Know

  • Source: MedPage Today
  • Published: May 17, 2026 at 18:38 UTC
  • Category: Health
  • Topics: #medicine · #health · #clinical · #intensity-ultrasound-shatters · #kidney-stones · #trial-patients

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Curated by GlobalBR News · May 17, 2026

🇧🇷 Resumo em Português

O Brasil pode estar a um passo de uma revolução no tratamento de cálculos renais: um dispositivo de ultrassom de baixa intensidade conseguiu fragmentar pedras nos rins em 70% dos pacientes testados no ensaio clínico SOUND, sem a necessidade de cirurgias invasivas ou exposição à radiação. A tecnologia, que pode ser aplicada diretamente no consultório médico, promete reduzir custos e acelerar a recuperação dos pacientes, um alívio para os mais de 1,5 milhão de brasileiros que sofrem com essa condição anualmente.

O método inovador, ainda em fase de testes, se diferencia por sua simplicidade e segurança, já que não emite radiação e pode ser realizado em ambiente ambulatorial. Atualmente, os principais tratamentos para litíase renal no Brasil incluem litotripsia extracorpórea por ondas de choque (LECO), que, embora eficaz, expõe o paciente à radiação, ou procedimentos cirúrgicos mais agressivos. A nova abordagem, além de minimizar riscos, poderia democratizar o acesso ao tratamento, especialmente em regiões com infraestrutura hospitalar limitada, onde a LECO nem sempre está disponível.

Caso os resultados se confirmem em estudos maiores, o dispositivo poderá se tornar uma opção viável para o Sistema Único de Saúde (SUS), reduzindo filas de espera e custos com internações. A próxima fase deve incluir testes em larga escala para validar a eficácia a longo prazo e a possibilidade de adoção em clínicas públicas e privadas.

🇪🇸 Resumen en Español

Un nuevo avance médico podría revolucionar el tratamiento de los cálculos renales. Según el ensayo clínico SOUND, un dispositivo de ultrasonidos de baja intensidad logró fragmentar piedras en el riñón en el 70% de los pacientes, sin necesidad de cirugía invasiva ni exposición a radiación.

El método, probado en consultas médicas y sin efectos secundarios graves, representa un salto cualitativo frente a las técnicas tradicionales, como la litotricia extracorpórea por ondas de choque, que requiere anestesia y puede dañar tejidos sanos. Para los hispanohablantes, este hallazgo es especialmente relevante, ya que los cálculos renales afectan a un porcentaje significativo de la población en países con dietas ricas en sal y proteínas, como España y gran parte de Latinoamérica. La posibilidad de tratar el problema de forma ambulatoria, rápida y sin riesgos de irradiación abre una puerta a soluciones más seguras y accesibles para millones de personas.