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| ID | Type | Description | Link |
|---|---|---|---|
| P01DK043881 | U.S. NIH Grant/Contract | View source | |
| CDMRP-SC220095 | Other Grant/Funding Number | CDMRP |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Congressionally Directed Medical Research Programs | FED |
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The purpose of this study is to determine whether new software processing of ultrasound images can improve detection and size determination of kidney stones.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verasonics Data Acquisition System (VDAS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Bailey | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington, Department of Urology | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27393000 | Result | May 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. | |
| 28847171 | Result | Cunitz 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2025 | Nov 4, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |