Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

Renal Calculi Clinical Trial

Official title:

Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03873259
• Other study ID #: SITE00000349
• Secondary ID: 5P01DK043881-22
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 8, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Calculi
• Ureteral Calculi
• Ureterolithiasis

Intervention

Device:
• Burst Wave Lithotripsy
Fragment upper urinary tract stones

Locations

Country	Name	City	State
United States	IU Health North Hospital	Carmel	Indiana
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Area of Tissue Injury	The primary safety endpoint is the area of hemorrhage observed through direct visualization with the ureteroscope.	Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
Primary	Effectiveness - Volume of Fragments < 2 mm	The primary effectiveness endpoint is the volume fraction of stone fragments less than 2 mm relative to the original stone volume.	Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
Secondary	Safety - Adverse Event Assessment	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	out to 120 days post-procedure
Secondary	Effectiveness - Time to Full Comminution	projected time to full comminution defined as the time at which no fragments would be = 2 mm	Day 0 - the day of the experimental procedure immediately following the acoustic procedure.

External Links

•   Sponsor Website