NCT02214836

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2015Dec 2027

First Submitted

Initial submission to the registry

August 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

12 years

First QC Date

August 7, 2014

Last Update Submit

November 24, 2025

Conditions

Kidney StonesNephrolithiasisUrolithiasisUreter Stones

Keywords

kidney stonesultrasound imagingureter stones

Outcome Measures

Primary Outcomes (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.

    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.

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.

    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.

Study Arms (1)

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.

Device: Verasonics Data Acquisition System (VDAS)

Interventions

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.

Also known as: Verasonics Ultrasound Engine
Kidney stones

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington, Department of Urology

Seattle, Washington, 98195, United States

Location

Related Publications (2)

  • 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.

    PMID: 27393000RESULT

  • 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.

    PMID: 28847171RESULT

MeSH Terms

Conditions

Kidney CalculiNephrolithiasisUrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Bailey

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Engineer

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 12, 2014

Study Start

January 1, 2015

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations

US(1)