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Ultrasound Imaging of Kidney Stones and Lithotripsy

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ClinicalTrials.gov Identifier: NCT02214836
Recruitment Status : Unknown
Verified October 2017 by Michael Bailey, University of Washington.
Recruitment status was:  Recruiting
First Posted : August 12, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Michael Bailey, University of Washington

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Stones Nephrolithiasis Urolithiasis Ureter Stones Device: Verasonics Data Acquisition System (VDAS) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultrasound Imaging of Kidney Stones and Lithotripsy
Actual Study Start Date : October 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kidney stones

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.

Device: Verasonics Data Acquisition System (VDAS)
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.
Other Name: Verasonics Ultrasound Engine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

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): NCT02214836


Contacts
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Contact: Michael Bailey, PhD 206-685-8618 bailey@apl.washington.edu
Contact: Barbrina Dunmire 206-685-6953 mrbean@uw.edu

Locations
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United States, Washington
University of Washington, Department of Urology Recruiting
Seattle, Washington, United States, 98195
Contact: Jonathan Harper, MD    206-543-3640    jdharper@uw.edu   
Principal Investigator: Jonathan Harper, MD         
Sponsors and Collaborators
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Michael Bailey University of Washington

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Responsible Party: Michael Bailey, Research Engineer, University of Washington
ClinicalTrials.gov Identifier: NCT02214836     History of Changes
Other Study ID Numbers: 35261
P01DK043881 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by Michael Bailey, University of Washington:
kidney stones
ultrasound imaging
ureter stones
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Urolithiasis
Ureteral Calculi
Ureterolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi
Ureteral Diseases