Home Diseases and Conditions Kidney Stones 

Kidney Stones 

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound is cleared to treat this condition within the US. Patients can seek commercial treatment at participating sites. There are also clinical trials that may be of interest to patients.

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with kidney stones. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

The FDA has granted De Novo clearance for the Stone ClearTM device for anesthesia free treatment of post-lithotripsy stone fragments, and this was followed by the approval of the Break WaveTM device for the breakage of kidney stones too large to pass on their own.  The result is that patients can get both stones broken up and assist in directing them to pass with these tools. 

How it Works
There are two mechanisms of action where this technology can help those with kidney stones.

The first mechanism is the ability to propel stones in the genitourinary track, which can be very helpful in patients with multiple stones or for those who have had extracorporeal shock wave lithotripsy (also referred to as ESWL), where there is the potential for the stone fragments to locate in the lower pole. As the energy is applied near the edge of the stone, there is an acoustic wave that spreads, resulting for stone movement.

A second mechanism of action is to use the energy in focused ultrasound to mechanically fragment the kidney stones into smaller pieces. These smaller pieces can pass through the urinary drainage system and exit in the urine. The SonoMotion’s Break Wave has recently achieved FDA approval for this purpose. 

The manufacturer for this work is spin-off company from the University of Washington, SonoMotion. They do not yet have a list of commercial centers providing this care, so interested patients can contact them at [email protected] or see if there is an opportunity to participate in the clinical trials which are still recruiting patients, listed below.  

Advantages
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications and lower cost. It has the ability to noninvasively break up and relocate kidney stones, (without anesthesia) and this treatment does not require any nephrotoxic or ionizing radiation components. Focused ultrasound can also be repeated, if needed.

Clinical Trials

A multi-center clinical trial is using low intensity focused ultrasound to treat patients with kidney stones in a pivotal trial.  

A multi-center clinical trial using focused ultrasound is being used to treat patients with kidney stones. 

A multi-center clinical trial using low intensity focused ultrasound to break up kidney stones has been completed. 

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement

Focused ultrasound treatment of kidney stones is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Chew BH, Harper JD, Sur RL, Chi T, De S, Buckley AR, Paterson RF, Wong VKF, Forbes CM, Hall MK, Kessler R, Bechis SK, Woo JR, Wang RC, Bayne DB, Bochinski D, Schuler TD, Wollin TA, Samji R, Sorensen MD Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial J Urol. 2024 Oct;212(4):580-589 

Li W, Feng T, Meng T, Guo G, Tu J, Zhang D, Ma Q. Steerable ultrasonic propulsion of rigid objects based on circular pressure modulation of a focused sectorial transducer array. Ultrasonics. 2025 Jan;145:107475. doi: 10.1016/j.ultras.2024.107475. Epub 2024 Sep 14. PMID: 39293232 

Sorensen M , Dunmire B , Thiel J ,  Cunitz BW , Burke BH, Levchak BJ , Popchoi C , Holmes AE , Kucewicz JC , Hall MK , Dighe M , Dai JC ,  Cormack FC ,  Liu Z, Bailey MR , Porter MP , Harper JD. Randomized Controlled Trial of Ultrasonic Propulsion-Facilitated Clearance of Residual Kidney Stone Fragments vs Observation. J Urol. 2024 Aug 14:101097JU0000000000004186.  doi:10.1097/JU.0000000000004186. PMID: 39146526 

Li W, Feng T, Meng T, Guo G, Tu J, Zhang D, Ma Q. Steerable ultrasonic propulsion of rigid objects based on circular pressure modulation of a focused sectorial transducer array. Ultrasonics. 2024 Sep 14;145:107475. doi: 10.1016/j.ultras.2024.107475. PMID: 39293232 

Biasiori-Poulanges L, Lukić B, Supponen O. Cavitation cloud formation and surface damage of a model stone in a high-intensity focused ultrasound field. Ultrason Sonochem. 2023 Dec 22;102:106738. doi: 10.1016/j.ultsonch.2023.106738. PMID: 38150955 

Maxwell AD, Kim GW, Furrow E, Lulich JP, Torre M, MacConaghy B, Lynch E, Leotta DF, Wang YN, Borofsky MS, Bailey MR. Development of a burst wave lithotripsy system for noninvasive fragmentation of ureteroliths in pet cats. BMC Vet Res. 2023 Sep 2;19(1):141. doi: 10.1186/s12917-023-03705-1. PMID: 37660015 

Click here for additional references from PubMed.