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Device
Ultrasound Therapy for Kidney Stones
N/A
Waitlist Available
Led By Jonathan Harper, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals presenting with at least one kidney stone
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of procedure to 14 months post-procedure
Awards & highlights
Study Summary
This trial is testing a new way to break up and move kidney stones without anesthesia.
Who is the study for?
This trial is for adults with kidney stones larger than 2mm but smaller or equal to 7mm. It's not for those with untreated infections, bleeding disorders, on anticoagulants they can't stop, certain aneurysms, a single kidney, urinary blockages, high comorbidity risks or cognitive impairments. Pregnant individuals and prisoners are excluded.Check my eligibility
What is being tested?
The study tests if ultrasound can help pass kidney stones without anesthesia by breaking them up (Break Wave Lithotripsy) and repositioning them (Ultrasonic Propulsion). This multi-center research does not involve blinding participants to the treatment.See study design
What are the potential side effects?
Potential side effects may include discomfort from the ultrasound process itself and possible complications from stone fragments passing through the urinary tract after being broken down.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one kidney stone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of procedure to 14 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of procedure to 14 months post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urinary Bladder Calculi (disorder)
Safety - incidence of return healthcare visits.
Secondary outcome measures
Urinary Bladder Calculi (disorder)
Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire
Effectiveness - need for further stone management
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
This study is currently in Phase 1 where all subjects undergo the investigational study.
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,331 Total Patients Enrolled
4 Trials studying Kidney Stones
3,793 Patients Enrolled for Kidney Stones
Indiana UniversityOTHER
980 Previous Clinical Trials
983,141 Total Patients Enrolled
4 Trials studying Kidney Stones
173 Patients Enrolled for Kidney Stones
VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
227,772 Total Patients Enrolled
1 Trials studying Kidney Stones
84 Patients Enrolled for Kidney Stones
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on blood thinners and cannot or will not stop them for a study procedure.I have had at least one kidney stone.I understand my role in giving consent and participating.People with spinal cord injury (Phase 2b only)You have a kidney stone that is bigger than 2 millimeters and smaller than or equal to 7 millimeters, as seen in medical images.I have a calcified aneurysm near my kidney stone.I currently have an infection that hasn't been treated.I am willing and able to participate in all follow-up activities.I have a bleeding disorder that hasn't been treated.I have only one kidney.I cannot be positioned for an ultrasound scan.I have a blockage in my urinary system that hasn't been fixed.You have already tried two other experimental treatments for the same health issue.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment group
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for this experiment currently?
"As the details on clinicaltrials.gov indicate, this research project is currently inactive and not recruiting candidates. It was initially posted in October 1st 2022 and last modified August 3rd 2022; yet, there are 63 other trials for which recruitment is ongoing at present."
Answered by AI
What results is this test endeavor hoping to accomplish?
"This clinical trial, which will span from the day of procedure to 4 months post-procedure, seeks to assess safety in terms of return healthcare visits. Secondary outcomes include efficacy measured by need for further stone management and adverse events associated with the device or procedure. Furthermore, patient quality of life is evaluated using a Wisconsin Stone Quality of Life questionnaire; this survey uses a scale ranging from 1-5 where lower scores indicate greater impact on patients' wellbeing."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Indiana University Health - North Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
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