Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

Not Applicable

Active, not recruiting

• Conditions: Renal Calculi; Ureteral Calculi
• Interventions: Device: Burst Wave Lithotripsy

• Registration Number: NCT03873259
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-03-09
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Study Start: 2019-08-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Burst Wave Lithotripsy	Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure.

Primary Outcome Measures

Name	Time	Method
Effectiveness - Volume of Fragments < 2 mm	Day 0 - the day of the experimental procedure immediately following the acoustic procedure.	The primary effectiveness endpoint is the volume fraction of stone fragments less than 2 mm relative to the original stone volume.
Safety - Area of Tissue Injury	Day 0 - the day of the experimental procedure immediately following the acoustic procedure.	The primary safety endpoint is the area of hemorrhage observed through direct visualization with the ureteroscope.

Secondary Outcome Measures

Name	Time	Method
Safety - Adverse Event Assessment	out to 120 days post-procedure	The secondary safety outcome is the documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events typically associated with shock wave lithotripsy (SWL) and URS
Effectiveness - Time to Full Comminution	Day 0 - the day of the experimental procedure immediately following the acoustic procedure.	projected time to full comminution defined as the time at which no fragments would be ≤ 2 mm

Trial Locations

Locations (2)

IU Health North Hospital; 🇺🇸 Carmel, Indiana, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States