Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study

Официальное название

A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones

Обзор

This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else. Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.

Вмешательства

• Устройство Break Wave extracorporeal lithotripsy
  The Break Wave device will be used to exert a low amplitude burst of ultrasound waves focused at the kidney stone. The primary components of the device include an 85 mm aperture diameter therapy probe driven by a high voltage generator. The therapy probe has a cavity in the middle to accommodate coaxial alignment of an ultrasound imaging probe for treatment guidance.

Первичные конечные точки

• Primary Effectiveness Outcome - Stone Fragmentation [Срок оценки: 12 weeks post-treatment]
• Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia [Срок оценки: 12 weeks post-treatment]

Вторичные конечные точки (3)

• Secondary effectiveness outcome - Stone Free Status [Срок оценки: 12 weeks post-treatment]
• Secondary effectiveness outcome - Residual fragment size [Срок оценки: 12 weeks post-treatment]
• Secondary safety outcome - Adverse events [Срок оценки: 12 weeks post-treatment]

Критерии участия

Критерии включения

• Individuals presenting with at least one kidney stone apparent on CT.
• Stones must be within the upper urinary tract.
• Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
• Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).

Критерии исключения

• Acute untreated urinary tract infection or urosepsis.
• Uncorrected bleeding disorders or coagulopathies.
• Pregnancy.
• Uncorrected obstruction distal to the stone.
• Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure.
• Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus.
• Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.).
• Patients unwilling to comply with the follow-up protocol, including post-procedure CT.
• Individuals under 18 years of age.
• Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse.
• Calcified abdominal aortic aneurysms or calcified renal artery aneurysms.
• Solitary kidney
• Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• University of California San Diego Health — San Diego
• University of California, San Francisco — San Francisco
• University of Washington Medical Center — Seattle

Канада · 3 центра

• University of Alberta, Division of Urology — Edmonton
• Vancouver General Hospital Stone Centre — Vancouver
• St. Michael's Unity Health Toronto — Toronto

Публикации

• Maxwell AD, Cunitz BW, Kreider W, Sapozhnikov OA, Hsi RS, Harper JD, Bailey MR, Sorensen MD. Fragmentation of urinary calculi in vitro by burst wave lithotripsy. J Urol. 2015 Jan;193(1):338-44. doi: 10.1016/j.juro.2014.08.009. Epub 2014 Aug 9. PMID 25111910
• Maxwell AD, MacConaghy B, Bailey MR, Sapozhnikov OA. An investigation of elastic waves producing stone fracture in burst wave lithotripsy. J Acoust Soc Am. 2020 Mar;147(3):1607. doi: 10.1121/10.0000847. PMID 32237849
• Sapozhnikov OA, Maxwell AD, Bailey MR. Modeling of photoelastic imaging of mechanical stresses in transparent solids mimicking kidney stones. J Acoust Soc Am. 2020 Jun;147(6):3819. doi: 10.1121/10.0001386. PMID 32611160
• Harper JD, Lingeman JE, Sweet RM, Metzler IS, Sunaryo PL, Williams JC Jr, Maxwell AD, Thiel J, Cunitz BW, Dunmire B, Bailey MR, Sorensen MD. Fragmentation of Stones by Burst Wave Lithotripsy in the First 19 Humans. J Urol. 2022 May;207(5):1067-1076. doi: 10.1097/JU.0000000000002446. Epub 2022 Mar 21. PMID 35311351
• 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. doi: 10.1097/JU.0000000000004091. Epub 2024 PMID 39254129

Идентификаторы

NCT: NCT03811171 · CLP-0001 · R44DK109779

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗