Back to resultsSafety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones
Primary Purpose
Kidney Stones, Nephrolithiasis, Urolithiasis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Propulse 1
Sponsored by
About this trial
This is an interventional basic science trial for Kidney Stones focused on measuring stones, kidney, stone fragments, lithotripsy
Eligibility Criteria
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.
Sites / Locations
- University of Washington Department of UrologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment with Ultrasonic Propulsion
Control
Arm Description
Subjects receive treatment with the Propulse 1 device. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter.
Subject follow same protocol as treatment group but do not receive the ultrasonic propulsion intervention.
Outcomes
Primary Outcome Measures
Measurement of stone displacement caused by ultrasound
The primary outcome measure is whether the stone moved a distance greater than 2 mm. Measurement is made by positioning calipers on the original stone location and the final stone location on the ultrasound image and measuring the distance between them.
Secondary Outcome Measures
Measurement of discomfort or adverse effects of treatment
The study measures any subject discomfort or adverse response to the device or procedure. The subject will be asked directly what feeling or discomfort, if any, they experienced with each treatment pulse. The subject will be asked to fill out a pain questionnaire before and after the research study. The subject will be contacted for several follow-up phone interviews to assess for adverse events and asked to return for a follow-up imaging examination.
Measurement of direction of movement of the stone
We test the ability to move the stone in a pre-determined direction with device application.
Measurement of effect of stone size
We will measure if fewer large ( > 5 mm) stones move versus small ( < 5 mm) stones.
Reduction in acute stone symptoms
We test the ability to move an acute obstructing stone and relieve the emergent symptoms. The study would be done in clinic or the emergency department after the symptoms have been managed.
Full Information
NCT ID
NCT02028559
First Posted
January 1, 2014
Last Updated
July 25, 2022
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT02028559
Brief Title
Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones
Official Title
Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones, Nephrolithiasis, Urolithiasis
Keywords
stones, kidney, stone fragments, lithotripsy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome Assessor evaluating the images/videos for stone motion is blind to the exposure condition.
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Ultrasonic Propulsion
Arm Type
Experimental
Arm Description
Subjects receive treatment with the Propulse 1 device. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subject follow same protocol as treatment group but do not receive the ultrasonic propulsion intervention.
Intervention Type
Device
Intervention Name(s)
Propulse 1
Intervention Description
Move kidney stones with Propulse 1 device.
Primary Outcome Measure Information:
Title
Measurement of stone displacement caused by ultrasound
Description
The primary outcome measure is whether the stone moved a distance greater than 2 mm. Measurement is made by positioning calipers on the original stone location and the final stone location on the ultrasound image and measuring the distance between them.
Time Frame
Measurement occurs at the time of treatment and is evaluated with each treatment pulse. The entire procedure, including screening, is expected to last 1 hour with treatment lasting approximately 30 minutes.
Secondary Outcome Measure Information:
Title
Measurement of discomfort or adverse effects of treatment
Description
The study measures any subject discomfort or adverse response to the device or procedure. The subject will be asked directly what feeling or discomfort, if any, they experienced with each treatment pulse. The subject will be asked to fill out a pain questionnaire before and after the research study. The subject will be contacted for several follow-up phone interviews to assess for adverse events and asked to return for a follow-up imaging examination.
Time Frame
At the time of treatment, weekly for 3 weeks following treatment (5-10 minute phone call), and follow-up imaging 4-6 weeks after treatment requiring about 1 hour of time.
Title
Measurement of direction of movement of the stone
Description
We test the ability to move the stone in a pre-determined direction with device application.
Time Frame
At the time of treatment. To be evaluated with each treatment pulse over a 1 hour study
Title
Measurement of effect of stone size
Description
We will measure if fewer large ( > 5 mm) stones move versus small ( < 5 mm) stones.
Time Frame
The stone size is measured during prescreening.
Title
Reduction in acute stone symptoms
Description
We test the ability to move an acute obstructing stone and relieve the emergent symptoms. The study would be done in clinic or the emergency department after the symptoms have been managed.
Time Frame
Approximately 30 minutes while being evaluated in clinic or in the emergency department.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbrina Dunmire
Email
mrbean@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Bailey
Email
bailey@apl.washington.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Harper, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Department of Urology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Burke
Email
burkeb3@uw.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Harper, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32940089
Citation
Harper JD, Metzler I, Hall MK, Chen TT, Maxwell AD, Cunitz BW, Dunmire B, Thiel J, Williams JC, Bailey MR, Sorensen MD. First In-Human Burst Wave Lithotripsy for Kidney Stone Comminution: Initial Two Case Studies. J Endourol. 2021 Apr;35(4):506-511. doi: 10.1089/end.2020.0725. Epub 2020 Nov 5.
Results Reference
derived
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Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones
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