Clinical Trials Square

Focused Ultrasound Therapy

Focused ultrasound is an early-stage, non-invasive, 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 ability to move stones in the genitourinary track can be very helpful in some patients. For patients with multiple stones or for those who have had extracorporeal shock wave lithotripsy (ESWL), there is a potential for the fragments to locate in the lower pole. This can have longer term implications, as the fragments can grow in size resulting in the need for another removal procedure.

The mechanism of moving the stones is based on applying focused ultrasound adjacent to the stone. As the energy is applied, there is an acoustic wave that spreads. When the wave hits the stone, the energy is transmitted to the stone, resulting in stone movement. Alterations in the location of the wave can enable directional control of the stone.

There are not any current, non-invasive options for moving kidney stones. Current methods could involve invasive treatments for moving stones, yet what commonly happens is that the location of the stone will determine which treatment options are available.

For certain patients, focused ultrasound could provide a non-invasive alternative to surgery with less risk of complications and lower cost.

Advantages:

  • Non-invasive ability to relocate kidney stones
  • Treatment does not require any nephrotoxic or ionizing radiation components
  • Treatments can be repeated, if needed

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound propulsion of kidney stones.

Regulatory Approval and Reimbursement

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

Notable Papers

Ghanem MA, Maxwell AD, Kreider W, Cunitz BW, Khokhlova VA, Sapozhnikov OA, Bailey MR. Field Characterization and Compensation of Vibrational Nonuniformity for a 256-Element Focused Ultrasound Phased Array. IEEE Trans Ultrason Ferroelectr Freq Control. 2018 Sep;65(9):1618-1630. doi: 10.1109/TUFFC.2018.2851188.

Oweis GF, Dunmire BL, Cunitz BW, Bailey MR. Non-invasive measurement of the temperature rise in tissue surrounding a kidney stone subjected to ultrasonic propulsion. Conf Proc IEEE Eng Med Biol Soc. 2015;2015:2576-9. doi: 10.1109/EMBC.2015.7318918.

Harper JD, Cunitz BW, Dunmire B, Lee FC, Sorensen MD, Hsi RS, Thiel J, Wessells H, Lingeman JE, Bailey MR. First in Human Clinical Trial of Ultrasonic Propulsion of Kidney Stones. J Urol. 2016 Apr;195(4P1):956-64. doi: 10.1016/j.juro.2015.10.131.

Ikeda T, Yoshizawa S, Koizumi N, Mitsuishi M, Matsumoto Y. Focused Ultrasound and Lithotripsy. Adv Exp Med Biol. 2016;880:113-29. doi: 10.1007/978-3-319-22536-4_7. Review.

Pfau A, Eckardt KU, Knauf F. [Diagnosis and treatment of nephrolithiasis. What is established?]. Internist (Berl). 2015 Dec;56(12):1361-8. doi: 10.1007/s00108-015-3758-0. Review. German.

Oweis GF, Dunmire BL, Cunitz BW, Bailey MR. Non-invasive measurement of the temperature rise in tissue surrounding a kidney stone subjected to ultrasonic propulsion. Conf Proc IEEE Eng Med Biol Soc. 2015;2015:2576-9. doi: 10.1109/EMBC.2015.7318918.

Abrol N, Kekre NS. Focused ultrasound guided relocation of kidney stones. Indian J Urol. 2015 Jan-Mar;31(1):28-32. doi: 10.4103/0970-1591.139577.

Click here for additional references from PubMed.

 

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