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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
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Effectiveness Outcome - Stone Fragmentation
Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia
Secondary study objectives
Secondary effectiveness outcome - Residual fragment size
Secondary effectiveness outcome - Stone Free Status
Secondary safety outcome - Adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
The arm receives the investigational Break Wave procedure.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- The stones must be located in the upper part of the urinary system.Your kidney stones can be treated with shock wave lithotripsy according to the American Urology Association (AUA) 2016 guidelines.Your kidney stones need to be a certain size, as measured by a CT scan, to be eligible for the study.Your body's shape or position makes it hard to use the Break Wave pulse treatment.You have other health conditions that may make it risky for you to have the Break Wave procedure, such as unusual body structures that could make it hard for the stone pieces to pass through.You have at least one kidney stone visible on a CT scan.You have a urinary tract infection that hasn't been treated yet.You have a bleeding disorder that has not been treated.There is a blockage downstream from the stone that has not been fixed.You are taking blood thinners and cannot stop taking them for the Break Wave procedure.The stones can't be seen clearly on the imaging or can't be targeted by the Break Wave therapy.You have calcified bulges in your belly or kidney arteries.You have only one kidney.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.