跳至主要内容
临床试验/NCT02214836
NCT02214836已完成不适用

Ultrasound Imaging of Kidney Stones and Lithotripsy

University of Washington2 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
219
试验地点
2
主要终点
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.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: Verasonics Data Acquisition System (VDAS) (Device)

结局指标

主要结局

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.

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Bailey

Research Engineer

University of Washington

研究点 (2)

Loading locations...

相似试验