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

The ability to propel stones in the genitourinary track 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. 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 near the edge of 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. Initial clinical trials have been done, but further research is needed before widespread adoption can occur.

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. This fragmentation has been done in the research lab, but it has not yet been accomplished in human clinical trials.

Ongoing work continues is being done by a spin-off company from the University of Washington, SonoMotion, on these ideas.

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

A clinical trial is enrolling patients by invitation for use of focused ultrasound to relocate their kidney stone.

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

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.

Wang YN, Simon JC, Cunitz BW, Starr FL, Paun M, Liggitt DH, Evan AP, McAteer JA, Liu Z, Dunmire B, Bailey MR. Focused ultrasound to displace renal calculi: threshold for tissue injury. J Ther Ultrasound. 2014 Mar 31;2:5. doi: 10.1186/2050-5736-2-5.

Connors BA, Evan AP, Blomgren PM, Hsi RS, Harper JD, Sorensen MD, Wang YN, Simon JC, Paun M, Starr F, Cunitz BW, Bailey MR, Lingeman JE. Comparison of tissue injury from focused ultrasonic propulsion of kidney stones versus extracorporeal shock wave lithotripsy. J Urol. 2014 Jan;191(1):235-41. doi: 10.1016/j.juro.2013.07.087.

Click here for additional references from PubMed.

 

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