Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones
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|ClinicalTrials.gov Identifier: NCT02028559|
Recruitment Status : Unknown
Verified May 2015 by Jonathan Harper, University of Washington.
Recruitment status was: Enrolling by invitation
First Posted : January 7, 2014
Last Update Posted : June 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Kidney Stones Nephrolithiasis Urolithiasis||Device: Propulse 1||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||June 2016|
Subjects receive treatment with study device.
Device: Propulse 1
Move kidney stones with Propulse 1 device.
- Stone movement [ Time Frame: At the time of treatment. To be evaluated with each treatment pulse - where each patient is expected to have an average of 40 pulses delivered over 1 hour ]Primary outcome measure is to move a stone a distance greater than 2 mm at the time of device application.
- Sensitivity [ Time Frame: At the time of treatment. To be evaluated with each treatment pulse - where each patient is expected to have an average of 40 pulses delivered over 1 hour ]Assess any patient discomfort or feeling at the time of device application. The patient will be asked directly what feeling or discomfort, if any, they experienced with the treatment pulse. The patient will be asked to fill out a pain questionnaire before and after the research study.
- Stone direction [ Time Frame: At the time of treatment. To be evaluated with each treatment pulse - where each patient is expected to have an average of 40 pulses delivered over 1 hour ]Test ability to move the stone in a pre-determined direction with device application.
- Stone size [ Time Frame: Established during prescreening ]Test the ability to move both large ( > 5 mm) and small ( < 5 mm) stones.
- Device safety [ Time Frame: 90 days ]Evaluation of adverse events from time of application to the 90 day follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028559
|United States, Washington|
|University of Washington Department of Urology|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Jonathan Harper, MD||University of Washington|