Ultrasound Imaging Technology for Kidney Stones

Overseen By Barbrina Dunmire

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Systemic disease, Renal disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

370 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether new software processing of ultrasound images can improve detection and size determination of kidney stones.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Verasonics Data Acquisition System (VDAS) for kidney stones?

Research shows that ultrasound technology, which is part of the Verasonics Data Acquisition System, can help accurately size kidney stones by measuring the acoustic shadow they cast, potentially improving treatment planning. ^{1 2 3 4 5}

Is ultrasound imaging technology for kidney stones safe for humans?

The research suggests that using ultrasound for kidney stones can reduce radiation exposure compared to CT scans, which implies a safety advantage. However, specific safety data for the ultrasound technology itself, such as the Verasonics Data Acquisition System (VDAS), is not detailed in the available studies. ^{1 6 7 8 9}

How is the Verasonics Data Acquisition System (VDAS) treatment for kidney stones different from other treatments?

The Verasonics Data Acquisition System (VDAS) is unique because it uses advanced ultrasound imaging techniques to accurately size kidney stones, which is a challenge with traditional ultrasound methods that often overestimate stone size. This system employs innovative methods like non-linear beamforming and stone-specific algorithms to improve the precision of stone measurement. ^{1 2 4 7 10}

Research Team

Michael Bailey

Principal Investigator

University of Washington

Eligibility Criteria

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.

Inclusion Criteria

Able to give informed consent

I am 21 years old or older.

You have kidney stones that can be seen on an x-ray.

Exclusion Criteria

Stones that cannot be seen on an x-ray.

I am under 21 years old.

I am unable to understand and give consent for treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging Procedure

Participants undergo ultrasound imaging to determine the size and location of kidney stones using the Verasonics Data Acquisition System (VDAS)

1 day

1 visit (in-person)

Data Analysis

Comparison of research ultrasound data with clinical data to assess accuracy

2 weeks

Follow-up

Participants are monitored for any additional data collection from existing medical records

2 weeks

Treatment Details

Interventions

• Verasonics Data Acquisition System (VDAS)

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

Participant Groups

Group I: Kidney stones Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Measuring the acoustic shadow behind kidney stones provides a more accurate estimation of their size compared to direct measurements, with an average error of only 0.0 ± 0.8 mm for shadow width across different ultrasound modalities.

Among the ultrasound imaging techniques tested, harmonic imaging was found to be the most accurate for measuring stone size, while the accuracy of stone width measurements decreased with greater imaging depth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Acoustic Shadow Width to Determine Kidney Stone Size with Ultrasound. Dunmire, B., Harper, JD., Cunitz, BW., et al.[2022]

Ultrasonography (US) demonstrated a sensitivity of 70.0% and specificity of 94.4% for detecting renal stones when compared to noncontrast enhanced computed tomography (NCCT), indicating it is a reliable imaging option.

US was particularly effective in detecting larger stones, with a higher detection rate for stones in other locations compared to the left upper calyx, and showed a strong correlation in size measurements with NCCT in 72% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of ultrasonography for the detection of renal stone. Kanno, T., Kubota, M., Sakamoto, H., et al.[2022]

The study involving 34 subjects and 115 renal stones found that the S-mode ultrasound technique accurately detected 84% of stones identified by CT, with 73% of stone size measurements within 2 mm of CT measurements.

S-mode ultrasound provided better visualization and sizing of kidney stones compared to a standard clinical ultrasound system, with measurements differing from CT by only 1.6 mm for stones and 0.8 mm for shadows, indicating its potential for improved clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stone-Mode Ultrasound for Determining Renal Stone Size. May, PC., Haider, Y., Dunmire, B., et al.[2019]

In a study of 210 patients with hydronephrosis, urinary stones were identified as the cause in 60% of cases, highlighting their significant role in this condition.

The detection rate of urinary stones increased with the severity of hydronephrosis, with rates of 50% for Grade 1, 61% for Grade 2, and 71.4% for Grade 3, but decreased in Grade 4, indicating a complex relationship between hydronephrosis severity and stone detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between grades of Hydronephrosis and detection of urinary stones by ultrasound imaging. Alshoabi, SA.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Proof of principle in vitro study of a prototype ultrasound technology to size stone fragments during ureteroscopy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Use of the Acoustic Shadow Width to Determine Kidney Stone Size with Ultrasound. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The efficacy of ultrasonography for the detection of renal stone. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Stone-Mode Ultrasound for Determining Renal Stone Size. [2019]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Association between grades of Hydronephrosis and detection of urinary stones by ultrasound imaging. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of an ultrasound-first clinical decision tool in emergency department patients with suspected nephrolithiasis: A randomized trial. [2022]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Express-diagnostic methods in urolithiasis for medical check-ups and screening]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Validating Automated Kidney Stone Volumetry in CT and Mathematical Correlation with Estimated Stone Volume Based on Diameter. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Ureteroscopic ultrasound technology to size kidney stone fragments: proof of principle using a miniaturized probe in a porcine model. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Feasibility of non-linear beamforming ultrasound methods to characterize and size kidney stones. [2019]