Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Nephrology, Nephrology, Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/14/2019 |
| Start Date: | January 2014 |
| End Date: | June 2024 |
A feasibility study to test the ability to move kidney stones using focused ultrasound. It is
the goal of our technology to: a) move stone fragments to a location within the kidney to
improve their chances of passage, and thus reduce the occurrence of additional symptomatic
events and retreatment or b) move a symptomatic stone to relieve symptoms and pain.
the goal of our technology to: a) move stone fragments to a location within the kidney to
improve their chances of passage, and thus reduce the occurrence of additional symptomatic
events and retreatment or b) move a symptomatic stone to relieve symptoms and pain.
Our research group has developed a new, non-invasive technology using low intensity focused
ultrasound to reposition kidney stones by imparting sufficient acoustic energy to physically
move a stone. The focused ultrasound pulses are similar to pulses that may be used in
elastography or acoustic radiation force imaging. Like conventional ultrasound, the probe is
placed in contact with the patient's skin to image the stone following standard ultrasound
imaging procedure. The same probe is then used to focus the ultrasound and apply a burst (a
sequence of pulses) of acoustic force to push the stone. Brightness mode (B-mode) imaging is
interleaved with the "pushing" pulses (Push-mode) to monitor stone movement. The user
controls the burst amplitude. For patient safety, there is a slight delay before the operator
can execute the next push.
ultrasound to reposition kidney stones by imparting sufficient acoustic energy to physically
move a stone. The focused ultrasound pulses are similar to pulses that may be used in
elastography or acoustic radiation force imaging. Like conventional ultrasound, the probe is
placed in contact with the patient's skin to image the stone following standard ultrasound
imaging procedure. The same probe is then used to focus the ultrasound and apply a burst (a
sequence of pulses) of acoustic force to push the stone. Brightness mode (B-mode) imaging is
interleaved with the "pushing" pulses (Push-mode) to monitor stone movement. The user
controls the burst amplitude. For patient safety, there is a slight delay before the operator
can execute the next push.
Inclusion Criteria:
- Individuals presenting to the University of Washington (UW) medical system or Veterans
Affairs Puget Sound healthcare system with at least one kidney stone or stone fragment
that is apparent on kidney-ureter-bladder (KUB) x-ray, computed tomography (CT), or
ultrasound imaging.
- Individuals scheduled for a lithotripsy procedure
- Individuals presenting to clinic or the emergency department with an acute obstructing
stone
Primary Exclusion Criteria:
- Individuals under 18 years of age
- Individuals with non-echogenic stones
- Individuals unable or unwilling to comply with the follow-up requirements
- Individuals with a coagulation abnormality or taking blood thinners or other
anticoagulant at clinically significant levels
- Individuals with mobility issues who are unable to comfortably lie for up to 30
minutes or roll from their back to their side Individuals belonging to a vulnerable
group (pregnant, mentally disabled, physically disabled, prisoner, etc.)
In addition, there are secondary exclusion criteria for subjects undergoing a symptomatic
stone event that are evaluated at the time of the event.
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