Ultrasound to Facilitate Stone Passage

University of Washington

Status: Enrolling

Conditions: Urinary Stone; Urinary Calculi

Treatments: Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04796792

5P01DK043881-26 (U.S. NIH Grant/Contract)

STUDY00011687

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

Phase I: Feasibility Treatment group

Experimental group

Description:

Initial phase of the trial to demonstrate feasibility. All subjects undergo the investigational intervention.

Treatment:

Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)

Phase 2a: Treatment Group of a randomized control trial

Experimental group

Description:

RCT phase of the trial to demonstrate superiority. All subjects undergo the investigational intervention.

Treatment:

Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)

Phase 2a: Control group of a randomized control trial

No Intervention group

Description:

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

Experimental group

Description:

Feasbility study of the investigational intervention in subjects with spinal cord injury.

Treatment:

Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)