Kidney StonesNCT02214836
Ultrasound Imaging of Kidney Stones and Lithotripsy
A study testing Verasonics Data Acquisition System (VDAS) in people with Kidney Stones and Nephrolithiasis, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine whether new software processing of ultrasound images can improve detection and size determination of kidney stones. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Kidney Stones, Nephrolithiasis, Urolithiasis
- What is being tested?
- Verasonics Data Acquisition System (VDAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with kidney stones that are visible on x-ray (i.e., calcium stones)
- Current CT scan within the 90-day pre-operative period
- Able to give informed consent
- Age 21 years or older
Who cannot join
- Inability to give informed consent
- Age less than 21 years
- Stones not visible on x-ray
- Patients with systemic disease or renal anatomical disorders (RTA, primary hyperparathyroidism, sarcoidosis, enteric hyperoxaluria, medullary sponge kidney)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, Department of Urology
Seattle, Washington, 98195
About this study
The purpose of this study is to determine whether new software processing of ultrasound images can improve detection and size determination of kidney stones.
Read the detailed description
The purpose of our research is to improve the ability to see kidney stones with ultrasound imaging. Specifically, we are testing how well new stone specific processing can find stones and show their size. Ultimately, better imaging can improve the care of future patients.
Patients with kidney stones or undergoing surgery for kidney stones will be recruited and consented.
We will image the kidney and ureter stones of consented subjects. We will place a water-based gel and ultrasound probe against the subject's skin on the back, sides, and abdomen. We will save the images and the raw electrical signals received from the probe and used to make the images. The images will be used to estimate the location and size of kidney stones in the kidney or ureter. The size and location will also be determined from x-ray and ultrasound images and reports already in the subject's medical record. And for recruited subjects who are already undergoing surgery in an existing clinical not research procedure, the surgeon will also measure location and size of stones seen in surgery. All these measurements of size and location of kidney stones will be compared to test the accuracy of the new ultrasound image processing.
After the examination, we will not ask anything more of subjects, but we will collect some information from their existing medical records. This information includes existing images of your stones, size of stones, location of stones, number of stones, type of stones, and treatment records. We will also record your weight, height, race, and ethnicity. Not all this information may be available. We will use what information is available. This additional information is used to test how well our ultrasound exam did. It also shows if we do better with certain groups of patients, for example, for certain stone types or body sizes.
- Conditions
- Kidney Stones, Nephrolithiasis, Urolithiasis, Ureter Stones
- Being tested
- Verasonics Data Acquisition System (VDAS)
- Keywords
- kidney stones, ultrasound imaging, ureter stones
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verasonics Data Acquisition System (VDAS)Device
Also called Verasonics Ultrasound Engine
Subjects will be imaged the Verasonics Data Acquisition System (VDAS) using conventional clinical outputs within FDA limits. The image processing has been modified. Stone location and size will be determined and compared to clinical determination of stone location and size.
| Study group | Role | What they receive |
|---|---|---|
| Kidney stones | Experimental | Device: Verasonics Data Acquisition System (VDAS)
Other Names:
Verasonics Data Acquisition System (VDAS) Verasonics Ultrasound Engine Subjects will be imaged the Verasonics Data Acquisition System (VDAS) using conventional clinical outputs within FDA limits. The image processing has been modified.
Subjects in this arm will be imaged by ultrasound by the VDAS. Stone location and size will be determined and compared to clinical determination of stone location and size. Receives: Device: Verasonics Data Acquisition System (VDAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and location of stones identified on research ultrasound vs. clinically. The outcome measured will be the accuracy new ultrasound images versus existing clinical data.
Number and location of stones will be measured in one research procedure at the time of the procedure. These will be compared to measurements of number and location made in the clinical surgery procedure and to measurements from clinical imaging.
Measured: Research data are collected on Day 1 (the day of the research imaging procedure). Clinical data are also available on Day 1. Clinical data will be downloaded by Day 7, and comparison will be made by Day 14.
Secondary outcomes (1)
Size of stones determined with research ultrasound vs. clinically. The outcome measured will be the accuracy new ultrasound images versus existing clinical data.
The size of stones will be measured in one research procedure at the time of the procedure. These will be compared to measurements of number and location made in the clinical surgery procedure and to measurements from clinical imaging.
Measured: Research data are collected on Day 1 (the day of the research imaging procedure). Clinical data are also available on Day 1. Clinical data will be downloaded by Day 7, and comparison will be made by Day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study start1 Jan 2015
- Primary completion15 Jun 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Michael Bailey, University of Washington
- Investigators
- Michael Bailey, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214836
- Sponsor's protocol ID
- STUDY00003444
- Other IDs
- P01DK043881, CDMRP-SC220095
- Status last verified
- Jul 2026
- First submitted
- 7 Aug 2014
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Researchers may contact the PI by email for data sharing.
Publications
Dunmire B, Harper JD, Cunitz BW, Lee FC, Hsi R, Liu Z, Bailey MR, Sorensen MD. Use of the Acoustic Shadow Width to Determine Kidney Stone Size with Ultrasound. J Urol. 2016 Jan;195(1):171-7. doi: 10.1016/j.juro.2015.05.111. Epub 2015 Aug 22.
PubMed 26301788May PC, Haider Y, Dunmire B, Cunitz BW, Thiel J, Liu Z, Bruce M, Bailey MR, Sorensen MD, Harper JD. Stone-Mode Ultrasound for Determining Renal Stone Size. J Endourol. 2016 Sep;30(9):958-62. doi: 10.1089/end.2016.0341.
PubMed 27393000Cunitz BW, Harper JD, Sorensen MD, Haider YA, Thiel J, May PC, Liu Z, Bailey MR, Dunmire B, Bruce M. Quantification of Renal Stone Contrast with Ultrasound in Human Subjects. J Endourol. 2017 Nov;31(11):1123-1130. doi: 10.1089/end.2017.0404. Epub 2017 Sep 28.
PubMed 28847171
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging of Kidney Stones and Lithotripsy
- ClinicalTrials.gov ID
- NCT02214836
- Acronym / sponsor ID
- STUDY00003444
- Conditions
- Kidney Stones, Nephrolithiasis, Urolithiasis, Ureter Stones
- Keywords
- kidney stones, ultrasound imaging, ureter stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Congressionally Directed Medical Research Programs
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether new software processing of ultrasound images can improve detection and size determination of kidney stones.
Detailed description
The purpose of our research is to improve the ability to see kidney stones with ultrasound imaging. Specifically, we are testing how well new stone specific processing can find stones and show their size. Ultimately, better imaging can improve the care of future patients.
Patients with kidney stones or undergoing surgery for kidney stones will be recruited and consented.
We will image the kidney and ureter stones of consented subjects. We will place a water-based gel and ultrasound probe against the subject's skin on the back, sides, and abdomen. We will save the images and the raw electrical signals received from the probe and used to make the images. The images will be used to estimate the location and size of kidney stones in the kidney or ureter. The size and location will also be determined from x-ray and ultrasound images and reports already in the subject's medical record. And for recruited subjects who are already undergoing surgery in an existing clinical not research procedure, the surgeon will also measure location and size of stones seen in surgery. All these measurements of size and location of kidney stones will be compared to test the accuracy of the new ultrasound image processing.
After the examination, we will not ask anything more of subjects, but we will collect some information from their existing medical records. This information includes existing images of your stones, size of stones, location of stones, number of stones, type of stones, and treatment records. We will also record your weight, height, race, and ethnicity. Not all this information may be available. We will use what information is available. This additional information is used to test how well our ultrasound exam did. It also shows if we do better with certain groups of patients, for example, for certain stone types or body sizes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney stones | Experimental | Device: Verasonics Data Acquisition System (VDAS)Device: Verasonics Data Acquisition System (VDAS) Other Names: Verasonics Data Acquisition System (VDAS) Verasonics Ultrasound Engine Subjects will be imaged the Verasonics Data Acquisition System (VDAS) using conventional clinical outputs within FDA limits. The image processing has been modified. Subjects in this arm will be imaged by ultrasound by the VDAS. Stone location and size will be determined and compared to clinical determination of stone location and size. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with kidney stones that are visible on x-ray (i.e., calcium stones)
- Current CT scan within the 90-day pre-operative period
- Able to give informed consent
- Age 21 years or older
Key exclusion criteria (4 listed)
- Inability to give informed consent
- Age less than 21 years
- Stones not visible on x-ray
- Patients with systemic disease or renal anatomical disorders (RTA, primary hyperparathyroidism, sarcoidosis, enteric hyperoxaluria, medullary sponge kidney)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verasonics Data Acquisition System (VDAS)Also: Verasonics Ultrasound EngineSubjects will be imaged the Verasonics Data Acquisition System (VDAS) using conventional clinical outputs within FDA limits. The image processing has been modified. Stone location and size will be determined and compared to clinical determination of stone location and size. | Device | Kidney stones |
Primary outcome
Number and location of stones identified on research ultrasound vs. clinically. The outcome measured will be the accuracy new ultrasound images versus existing clinical data.
Time frame: Research data are collected on Day 1 (the day of the research imaging procedure). Clinical data are also available on Day 1. Clinical data will be downloaded by Day 7, and comparison will be made by Day 14.
Number and location of stones will be measured in one research procedure at the time of the procedure. These will be compared to measurements of number and location made in the clinical surgery procedure and to measurements from clinical imaging.
1 secondary outcome
Size of stones determined with research ultrasound vs. clinically. The outcome measured will be the accuracy new ultrasound images versus existing clinical data.
Time frame: Research data are collected on Day 1 (the day of the research imaging procedure). Clinical data are also available on Day 1. Clinical data will be downloaded by Day 7, and comparison will be made by Day 14.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 26301788Dunmire B, Harper JD, Cunitz BW, Lee FC, Hsi R, Liu Z, Bailey MR, Sorensen MD. Use of the Acoustic Shadow Width to Determine Kidney Stone Size with Ultrasound. J Urol. 2016 Jan;195(1):171-7. doi: 10.1016/j.juro.2015.05.111. Epub 2015 Aug 22.
- Results publication: PubMed 27393000May PC, Haider Y, Dunmire B, Cunitz BW, Thiel J, Liu Z, Bruce M, Bailey MR, Sorensen MD, Harper JD. Stone-Mode Ultrasound for Determining Renal Stone Size. J Endourol. 2016 Sep;30(9):958-62. doi: 10.1089/end.2016.0341.
- Results publication: PubMed 28847171Cunitz BW, Harper JD, Sorensen MD, Haider YA, Thiel J, May PC, Liu Z, Bailey MR, Dunmire B, Bruce M. Quantification of Renal Stone Contrast with Ultrasound in Human Subjects. J Endourol. 2017 Nov;31(11):1123-1130. doi: 10.1089/end.2017.0404. Epub 2017 Sep 28.
- Individual participant dataSharing planned: Yes. Researchers may contact the PI by email for data sharing.
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Kidney Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bailey principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verasonics Data Acquisition System (VDAS) in people with Kidney Stones and Nephrolithiasis, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and location of stones identified on research ultrasound vs. clinically. The outcome measured will be the accuracy new ultrasound images versus existing clinical data. (time frame: Research data are collected on Day 1 (the day of the research imaging procedure). Clinical data are also available on Day 1. Clinical data will be downloaded by Day 7, and comparison will be made by Day 14.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214836, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.