← Back to Search

Extracorporeal Shock Wave Lithotripsy

Extracorporeal Lithotripsy for Kidney Stones

N/A
Waitlist Available
Research Sponsored by SonoMotion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks post-treatment
Awards & highlights

Study Summary

This trial is testing a new technology to break up kidney stones without surgery. Up to 30 people will be included, and the procedure can be done with different levels of anesthesia, from none to full anesthesia. Safety will be measured by side effects, unplanned visits to the doctor or emergency room, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and comparing CT images before and after the procedure.

Who is the study for?
This trial is for adults with kidney stones visible on CT scans, located in the upper urinary tract and fitting within specific size guidelines (≤10 mm for lower pole stones, ≤20 mm for others). It's not suitable for those with certain health risks, untreated infections, bleeding disorders, pregnancy, or if they can't stop blood thinners. Vulnerable individuals and minors are also excluded.Check my eligibility
What is being tested?
The study tests the Break Wave extracorporeal lithotripsy technology's safety and effectiveness in breaking up kidney stones without surgery. Up to 30 participants will undergo this procedure under various anesthesia levels at a hospital or clinic setting.See study design
What are the potential side effects?
Potential side effects include pain from stone passage after treatment, possible injury to surrounding tissues due to shock waves used in lithotripsy, bleeding complications especially if there's an underlying clotting disorder that hasn't been corrected before the procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Outcome - Stone Fragmentation
Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia
Secondary outcome measures
Secondary effectiveness outcome - Residual fragment size
Secondary effectiveness outcome - Stone Free Status
Secondary safety outcome - Adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
The arm receives the investigational Break Wave procedure.

Find a Location

Who is running the clinical trial?

SonoMotionLead Sponsor
1 Previous Clinical Trials
116 Total Patients Enrolled
1 Trials studying Kidney Stones
116 Patients Enrolled for Kidney Stones

Media Library

Break Wave Extracorporeal Lithotripsy (Extracorporeal Shock Wave Lithotripsy) Clinical Trial Eligibility Overview. Trial Name: NCT03811171 — N/A
Kidney Stones Research Study Groups: Treatment
Kidney Stones Clinical Trial 2023: Break Wave Extracorporeal Lithotripsy Highlights & Side Effects. Trial Name: NCT03811171 — N/A
Break Wave Extracorporeal Lithotripsy (Extracorporeal Shock Wave Lithotripsy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03811171 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this scientific experiment?

"Affirmative. According to the clinicaltrials.gov entry, this medical trial is currently recruiting and was initially posted on August 20th 2019. An additional 30 participants need to be found at 6 sites in order for the study to proceed as planned."

Answered by AI

Are there numerous sites in Canada conducting this clinical experiment?

"These medical sites are participating in the trial: University of Alberta, Division of Urology (Edmonton, AB), University of California San Francisco (San Fransisco, CA), and University of Washington Medical Center (Seattle wa). Additionally, 3 other locations have been chosen."

Answered by AI

What is the sample size of this clinical investigation?

"This trial requires 30 suitable participants, who must meet the inclusion criteria set by SonoMotion. The study will be conducted in two locations: Edmonton's University of Alberta Urology Department and San Francisco's University of California campus."

Answered by AI
Recent research and studies
~5 spots leftby May 2025