Ultrasound Technology to Fragment and Reposition Urinary Stones
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Safety - incidence of return healthcare visits.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Phase I: Feasibility Treatment group
Initial phase of the trial to demonstrate feasibility. All subjects undergo the investigational intervention.
干预措施: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP) (Device)
Phase 2a: Treatment Group of a randomized control trial
RCT phase of the trial to demonstrate superiority. All subjects undergo the investigational intervention.
干预措施: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP) (Device)
Phase 2a: Control group of a randomized control trial
RCT phase of the trial to demonstrate superiority. All subjects are the concurrent Control to the Phase 2a Treatment group. Subjects receive no intervention.
Phase 2b: Spinal Cord Injury Feasibility Study
Feasbility study of the investigational intervention in subjects with spinal cord injury.
干预措施: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP) (Device)
结局指标
主要结局
Safety - incidence of return healthcare visits.
时间窗: Day of procedure to 14 months post-procedure
Incidence of return health care visits associated with the device or procedure.
Effectiveness - stone comminution into fragments 2 mm or less.
时间窗: Day of procedure to 4 months posts procedure
Number of cases where the largest dimension of any residual stone in the study kidney is less than or equal to 2 mm.
次要结局
- Safety - incidence of adverse events (AEs)(Day of procedure to 4 months posts procedure)
- Effectiveness - % residual stone volume(Day of procedure to 4 months posts procedure)
- Effectiveness - need for further stone management(Day of procedure to 4 months posts procedure)
- Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire(Day of procedure to 14 months posts procedure)
研究者
Jonathan Harper, MD
Associate Professor, School of Medicine
University of Washington