Ultrasound to Facilitate Stone Passage

Официальное название

Ultrasound Technology to Fragment and Reposition Urinary Stones

Обзор

This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.

Подробное описание

This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.

Subjects will be included across three phases:

* Phase 1: 20 subjects to demonstrate initial feasibility * Phase 2a: 100 subjects for a two-arm (50:50) randomized control trial (RCT) * Phase 2b: 20 subjects to demonstrate feasibility in individuals with spinal cord injury (SCI)

This study has completed Phase 1. The study is currently recruiting for Phase 2b. Recruitment has not yet started for Phase 2a.

Up to 3 distinct targets may be treated per subject. The maximum total dose exposure is 30 minutes for one session. Subjects may return after at least 21 days and after all AEs have resolved for an additional session on the same side. Subjects may return after imaging follow-up for inclusion of their contralateral side.

Вмешательства

• Устройство Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)
  Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compre

Первичные конечные точки

• Safety - incidence of return healthcare visits. [Срок оценки: Day of procedure to 14 months post-procedure]
• Effectiveness - stone comminution into fragments 2 mm or less. [Срок оценки: Day of procedure to 4 months posts procedure]

Вторичные конечные точки (4)

• Safety - incidence of adverse events (AEs) [Срок оценки: Day of procedure to 4 months posts procedure]
• Effectiveness - % residual stone volume [Срок оценки: Day of procedure to 4 months posts procedure]
• Effectiveness - need for further stone management [Срок оценки: Day of procedure to 4 months posts procedure]
• Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire [Срок оценки: Day of procedure to 14 months posts procedure]

Критерии участия

Критерии включения

• Individuals presenting with at least one kidney stone
• Stone with maximum dimension > 2 mm and ≤ 7 mm as determined by clinical imaging
• Individuals with SCI - (Phase 2b only)

Критерии исключения

• Individuals under 18 years of age
• Individuals who are pregnant or who are trying to get pregnant
• Prisoners
• with cognitive impairment that would limit their ability to comprehend their role in consent or participation.
• Individuals who are unable to read or understand English
• Individuals who are unable or unwilling to participate in follow up activities
• Individuals who cannot be positioned for ultrasound imaging
• Individuals with uncorrected bleeding disorders or coagulopathies
• Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure
• Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure
• Individuals with a solitary kidney
• Individuals with an uncorrected urinary tract obstruction
• Individuals with an untreated infection
• Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure
• Individuals who have received two previous investigational procedures for the same stone target
• Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Indiana University Health - North Hospital — Carmel
• VA Puget Sound Health Care System — Seattle
• University of Washington — Seattle

Публикации

• May PC, Kreider W, Maxwell AD, Wang YN, Cunitz BW, Blomgren PM, Johnson CD, Park JSH, Bailey MR, Lee D, Harper JD, Sorensen MD. Detection and Evaluation of Renal Injury in Burst Wave Lithotripsy Using Ultrasound and Magnetic Resonance Imaging. J Endourol. 2017 Aug;31(8):786-792. doi: 10.1089/end.2017.0202. Epub 2017 Jun 16. PMID 28521550
• 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
• Harper JD, Metzler I, Hall MK, Chen TT, Maxwell AD, Cunitz BW, Dunmire B, Thiel J, Williams JC, Bailey MR, Sorensen MD. First In-Human Burst Wave Lithotripsy for Kidney Stone Comminution: Initial Two Case Studies. J Endourol. 2021 Apr;35(4):506-511. doi: 10.1089/end.2020.0725. Epub 2020 Nov 5. PMID 32940089
• Ramesh S, Chen TT, Maxwell AD, Cunitz BW, Dunmire B, Thiel J, Williams JC, Gardner A, Liu Z, Metzler I, Harper JD, Sorensen MD, Bailey MR. In Vitro Evaluation of Urinary Stone Comminution with a Clinical Burst Wave Lithotripsy System. J Endourol. 2020 Nov;34(11):1167-1173. doi: 10.1089/end.2019.0873. Epub 2020 Mar 20. PMID 32103689
• Dai JC, Sorensen MD, Chang HC, Samson PC, Dunmire B, Cunitz BW, Thiel J, Liu Z, Bailey MR, Harper JD. Quantitative Assessment of Effectiveness of Ultrasonic Propulsion of Kidney Stones. J Endourol. 2019 Oct;33(10):850-857. doi: 10.1089/end.2019.0340. Epub 2019 Sep 25. PMID 31333058
• Maxwell AD, Wang YN, Kreider W, Cunitz BW, Starr F, Lee D, Nazari Y, Williams JC Jr, Bailey MR, Sorensen MD. Evaluation of Renal Stone Comminution and Injury by Burst Wave Lithotripsy in a Pig Model. J Endourol. 2019 Oct;33(10):787-792. doi: 10.1089/end.2018.0886. Epub 2019 May 27. PMID 31016998
• 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(4 Pt 1):956-64. doi: 10.1016/j.juro.2015.10.131. Epub 2015 Oct 30. PMID 26521719
• 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

Идентификаторы

NCT: NCT04796792 · STUDY00011687 · 5P01DK043881-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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