Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-30 @ 4:38 PM
Study NCT ID:
NCT05654935
Status:
WITHDRAWN
Last Update Posted:
2023-01-10
First Post:
2022-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telerobotic Ultrasound for Carotid Imaging - Feasibility Study
Sponsor:
Rush University Medical Center
Organization:
Study Overview
Official Title:
Telerobotic Ultrasound for Carotid Imaging - Feasibility Study
Status:
WITHDRAWN
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to procure funding and technical logistics
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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:
1. Telerobotic ultrasonography produces diagnostic images of the carotid arteries at a rate that is non-inferior to those obtained using standard manual acquisition.
2. Telerobotic ultrasonography can detect carotid atherosclerotic plaques at a rate that is non-inferior to the gold standard of manual acquisition.
IMPLICATIONS:
Realizing our study aims could mark a new era in ultrasonography. There are wide applications for telerobotic carotid ultrasonography in atherosclerosis screening. Furthermore, establishing the noninferiority of telerobotic carotid ultrasonography acquisition will provide a rationale for further studies in telerobotic ultrasonography, including echocardiography. This in turn has even wider clinical applications such as emergency studies in hospitals during weekends and after-hours. In addition, this could pave the way for use in disaster areas and battle zones where expert sonographers may not be available on-site.
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:
1. Telerobotic ultrasonography produces diagnostic images of the carotid arteries at a rate that is non-inferior to those obtained using standard manual acquisition.
2. Telerobotic ultrasonography can detect carotid atherosclerotic plaques at a rate that is non-inferior to the gold standard of manual acquisition.
IMPLICATIONS:
Realizing our study aims could mark a new era in ultrasonography. There are wide applications for telerobotic carotid ultrasonography in atherosclerosis screening. Furthermore, establishing the noninferiority of telerobotic carotid ultrasonography acquisition will provide a rationale for further studies in telerobotic ultrasonography, including echocardiography. This in turn has even wider clinical applications such as emergency studies in hospitals during weekends and after-hours. In addition, this could pave the way for use in disaster areas and battle zones where expert sonographers may not be available on-site.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: