Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT03555006
Status:
TERMINATED
Last Update Posted:
2022-10-07
First Post:
2018-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist
Sponsor:
Centre Hospitalier Régional Metz-Thionville
Organization:
Study Overview
Official Title:
Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist for the Realization of Some Exploration Indications by Ultrasound
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
because of the health crisis, organizational constraints and the lack of medical and paramedical staff
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELECHO
Brief Summary:
This study tries to evaluate the non-inferiority quality and safety of ultrasound examinations realise by electro-radiology assistant with a remote radiologist compared to those realize by electro-radiology assistant with a referent radiologist on site.
Detailed Description:
The number of requests for medical imaging examinations is clearly growing while there is an understaffing among the radiologists. The solution is the amelioration of information transmission technologies, for organize a territorial teleradiology in order to care duty. Currently, in the ultrasound field, the investigators can't realize image transfer because analyse and expertise are made during examination and only reading of fixed images can't be enough for the examination interpretation.
The most part of other developed countries recognize a paramedical job devoted to ultrasound. Tele-ultrasound is used in expert resort, for example during high-risk pregnancy.
A French society commercializes tele-ultrasound robots, arranged by a caregiver beside sick person and a tele-radiologist realize acquisition of information and images with remote commands from robot.
The CHR Metz-Thionville has a cooperation protocol between electro-radiology assistants and radiologists for the ultrasound practical, endorsed by Lorraine ARS and HAS (French health organizations) since 2012, and currently national impact.
This study purpose to evaluation the non-inferiority of agreement between two interpretations of the same ultrasound realize by an electro-radiology assistant on the one hand by two radiologists present in the radiology service and on the other hand, one radiologist in by the radiology service and one remote radiologist.
The most part of other developed countries recognize a paramedical job devoted to ultrasound. Tele-ultrasound is used in expert resort, for example during high-risk pregnancy.
A French society commercializes tele-ultrasound robots, arranged by a caregiver beside sick person and a tele-radiologist realize acquisition of information and images with remote commands from robot.
The CHR Metz-Thionville has a cooperation protocol between electro-radiology assistants and radiologists for the ultrasound practical, endorsed by Lorraine ARS and HAS (French health organizations) since 2012, and currently national impact.
This study purpose to evaluation the non-inferiority of agreement between two interpretations of the same ultrasound realize by an electro-radiology assistant on the one hand by two radiologists present in the radiology service and on the other hand, one radiologist in by the radiology service and one remote radiologist.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: