Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-08

Study Completion Date

2026-04-30

Brief Summary

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Burst Wave Lithotripsy (BWL) is a novel method of urinary stone fragmentation that uses 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 compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. This is a single-arm feasibility study to test the ability of BWL to comminute (fragment) stones in humans.

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Detailed Description

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This is a two-center, single-arm, feasibility study. The two centers are located within the US and include: University of Washington (UW) School of Medicine and Indiana University (IU) Health Urology Clinic.

The investigative study will be performed in the operating room prior to a standard-of-care (SoC) ureteroscopic (URS) laser lithotripsy procedure. The subject will already be under anesthesia. Stones will be limited to ≤ 12 mm.

The study has one (treatment) arm and is approved to enroll up to 40 subjects (with the intent to treat 20 subjects). All subjects will be treated with the same output parameters for up to a maximum of 10 minutes per stone. The output parameters are nominally defined as:

* 350 kil0Hertz (kHz) acoustic frequency
* 7 MegaPascals (MPa) peak negative pressure
* 20 cycle pulse duration
* 17 Hz pulse repetition frequency

A maximum of 3 stones can be treated per subject.

Safety will be monitored by visual observation of the tissue with an ureteroscopic camera, the self-reported occurrences of adverse events, and occurrences of unplanned emergency department or clinic visits. Fragmentation will be measured by visual observation with an ureteroscopic camera and direct measure of stones removed by basket after the procedure.

Conditions

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Renal Calculi Ureteral Calculi

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Some outcomes assessors will be blinded to the treatment conditions. This will include review of video data for tissue injury.

Study Groups

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Treatment Group

Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure.

Group Type EXPERIMENTAL

Burst Wave Lithotripsy

Intervention Type DEVICE

Fragment upper urinary tract stones

Interventions

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Burst Wave Lithotripsy

Fragment upper urinary tract stones

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Individuals presenting with at least one kidney stone apparent on CT
* Individuals scheduled for clinical stone removal via ureteroscopy (URS)

Exclusion Criteria

* Individuals under 18 years of age
* Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.)
* Individuals with uncorrected bleeding disorders or coagulopathies
* Individuals taking a clinically significant anticoagulant dose at the time of the procedure
* Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm
* Individuals with a solitary kidney
* Individuals with a comorbidity risks which, at the discretion of the physician, would make the patient a poor candidate for the BWL procedure

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No