Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295438
Status:
TERMINATED
Last Update Posted:
2016-09-15
First Post:
2006-02-21
Brief Title:
Robot-based Tele-echography II - A Comparative Study
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Robot-based Tele-echography II - A Comparative Study Using Two Echographic Modalities for Diagnosis of Thoracoabdominal Injuries at the Trauma Center of the Grenoble University Hospital
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No diagnosis of visceral lesion was placed on 18 included patients The study is thus stopped prematurely for ethical reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical trial is to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods The first method is a robot-based tele-echography performed by radiologists in a remote location The second is bedside echography performed by emergency physicians according to the FAST Focussed Assessment by Sonography of Trauma examination
Detailed Description:
1 Principal objective to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods robot-based tele-echography performed by radiologists in a remote location vs bedside echography performed by emergency physicians according to the FAST examination
2 Objective 2 after the realization of a gold standard method if there is a concordance between the two different echographic methods sensitivity and specificity are estimated If not the evaluation of sensitivity and specificity of each method with analysis of their discordance is performed
3 Objective 3 qualitative evaluation of each echographic method by the patient and the physicians
4 Material and methods This therapeutic mono-centre prospective randomized cross-over open controlled trial is being conducted in 70 patients All the patients will have the two different echographic methods in a sequential but randomized way The robot-based tele-echography is performed by a radiologist in the North University Hospital of Grenoble The bedside echography is performed by the emergency physicians in the trauma center in the South University Hospital of Grenoble
2 Objective 2 after the realization of a gold standard method if there is a concordance between the two different echographic methods sensitivity and specificity are estimated If not the evaluation of sensitivity and specificity of each method with analysis of their discordance is performed
3 Objective 3 qualitative evaluation of each echographic method by the patient and the physicians
4 Material and methods This therapeutic mono-centre prospective randomized cross-over open controlled trial is being conducted in 70 patients All the patients will have the two different echographic methods in a sequential but randomized way The robot-based tele-echography is performed by a radiologist in the North University Hospital of Grenoble The bedside echography is performed by the emergency physicians in the trauma center in the South University Hospital of Grenoble
Study Oversight
Has Oversight DMC:
None
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?:
None