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临床试验/NCT05654935
NCT05654935撤回不适用

Telerobotic Ultrasound for Carotid Imaging - Feasibility Study

Rush University Medical Center0 个研究点开始时间: 2014年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Diagnostic Quality of Telerobotic Ultrasound.

研究概览

简要总结

In this proposal, the investigators will demonstrate the feasibility and noninferiority of telerobotic ultrasonography as compared to traditional manual acquisition in performing a limited carotid Duplex examination and in carotid plaque detection.

详细描述

BACKGROUND

Ultrasonography is an inexpensive, noninvasive, radiation-free diagnostic tool that is indispensable in modern medicine. Carotid intima-media thickness (IMT) and carotid atherosclerotic plaque detection have been powerful screening tools for identifying patients at risk for cardiovascular events; including myocardial infarction, cardiac death, and stroke. The need for trained sonographers by the patient side to perform quality ultrasound studies has limited the accessibility to this imaging tool, both in terms of location and time of day. Robotic arms controlled remotely over the internet, by trained sonographers, can potentially provide easier and more ubiquitous access to ultrasonography in and outside traditional medical facilities, including remote villages in underdeveloped countries, disaster areas, battle zones, etc. In this proposal, the investigators will demonstrate the feasibility and noninferiority of telerobotic ultrasonography as compared to traditional manual acquisition in performing a limited carotid Duplex examination and in carotid plaque detection.

HYPOTHESIS:

Telerobotic ultrasound performed by an experienced sonographer over the Internet produces diagnostic images with quality similar to manual conventional imaging.

AIMS:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Diagnostic Quality of Telerobotic Ultrasound.

时间窗: 3 months

Gray scale examination of the right and left carotid arteries in 3 views: short axis view of the common carotid artery, long axis view of carotid bifurcation, and short axis view post bifurcation. Images will be analyzed for: 1. Diagnostic image quality (diagnostic vs. non-diagnostic quality) by 2 reviewers blinded to image acquisition modality (manual vs. telerobotic). 2. Image quality graded on a scale from 1 to 4 by the same two reviewers as 1) poor/non-diagnostic; 2) fair; 3) acceptable; 4) good/excellent. Evaluation for diagnostic quality will be performed by two independent observers who will be blinded to the modality of image acquisition. Disagreement between observers will be resolved by a third blinded observer.

次要结局

  • Subject Experience with Manual vs. Telerobotic Ultrasound(3 months)
  • Carotid Intima-Media Thickness (CIMT) Measurement(3 months)

研究者

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

Rami Doukky

Professor of Medicine, Preventive Medicine, and Radiology, Rush University Medical Center; Interim Chief Division of Cardiology, John H. Stroger, Jr. Hospital of Cook County

Rush University Medical Center

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