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Extracorporeal Lithotripsy for Kidney Stones
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.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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