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Ultrasound Imaging

Ultrasound Imaging Technology for Kidney Stones

N/A

Waitlist Available

Led By Michael Bailey

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21 years or older

Be older than 18 years old

Must not have

Inability to give informed consent

Age less than 21 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if new software can help find kidney stones and measure their size.

Who is the study for?

This trial is for adults over 21 who have kidney stones visible on x-ray and can consent to participate. They must also have a recent CT scan. It's not for those under 21, unable to consent, with stones invisible on x-ray, or with certain systemic diseases or renal disorders.

What is being tested?

The study tests if new software that processes ultrasound images can better detect and size kidney stones using the Verasonics Data Acquisition System (VDAS).

What are the potential side effects?

Since this trial involves imaging rather than medication or invasive procedures, side effects are minimal but may include discomfort during the ultrasound process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand and give consent for treatment.

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I am under 21 years old.

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I have a condition affecting my kidneys or body's system, like RTA or sarcoidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Size of stones determined with research ultrasound vs. clinically. The outcome measured will be the accuracy new ultrasound images versus existing clinical data.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Kidney stonesExperimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met