Clinical trial NCT03811171: Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
Official title: A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Renal Calculi
Urinary Calculi
Keywords: Stone
Lithotripsy
Calculi
Lead sponsor: SonoMotion
Sponsor class: INDUSTRY
First posted: 2019-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else.

Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.


Eligibility criteria: Inclusion Criteria:

* Individuals presenting with at least one kidney stone apparent on CT.
* Stones must be within the upper urinary tract.
* Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
* Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).

Exclusion Criteria:

* Acute untreated urinary tract infection or urosepsis.
* Uncorrected bleeding disorders or coagulopathies.
* Pregnancy.
* Uncorrected obstruction distal to the stone.
* Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure.
* Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus.
* Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.).
* Patients unwilling to comply with the follow-up protocol, including post-procedure CT.
* Individuals under 18 years of age.
* Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse.
* Calcified abdominal aortic aneurysms or calcified renal artery aneurysms.
* Solitary kidney
* Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.

Primary outcomes:
measure: Primary Effectiveness Outcome - Stone Fragmentation
timeFrame: 12 weeks post-treatment
measure: Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia
timeFrame: 12 weeks post-treatment
Secondary outcomes:
measure: Secondary effectiveness outcome - Stone Free Status
timeFrame: 12 weeks post-treatment
measure: Secondary effectiveness outcome - Residual fragment size
timeFrame: 12 weeks post-treatment
measure: Secondary safety outcome - Adverse events
timeFrame: 12 weeks post-treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego Health
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Edmonton
country: Canada
facility: University of Alberta, Division of Urology
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital Stone Centre
state: British Columbia
city: Toronto
country: Canada
facility: St. Michael's Unity Health Toronto
state: Ontario
Study officials:
References:
citation: 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.
citation: Maxwell AD, MacConaghy B, Bailey MR, Sapozhnikov OA. An investigation of elastic waves producing stone fracture in burst wave lithotripsy. J Acoust Soc Am. 2020 Mar;147(3):1607. doi: 10.1121/10.0000847.
citation: Sapozhnikov OA, Maxwell AD, Bailey MR. Modeling of photoelastic imaging of mechanical stresses in transparent solids mimicking kidney stones. J Acoust Soc Am. 2020 Jun;147(6):3819. doi: 10.1121/10.0001386.
citation: Harper JD, Lingeman JE, Sweet RM, Metzler IS, Sunaryo PL, Williams JC Jr, Maxwell AD, Thiel J, Cunitz BW, Dunmire B, Bailey MR, Sorensen MD. Fragmentation of Stones by Burst Wave Lithotripsy in the First 19 Humans. J Urol. 2022 May;207(5):1067-1076. doi: 10.1097/JU.0000000000002446. Epub 2022 Mar 21.