Ignite Creation Date:
2024-05-06 @ 6:17 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05617326
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2022-11-08
Brief Title:
Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Fondation Ophtalmologique Adolphe de Rothschild
Study Overview
Official Title:
Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound Cluster Randomized Controlled Prospective Multicenter Study in Two Parallel Groups 11 in Open-label
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DACEP
Brief Summary:
Abdominal aortic aneurysm AAA is a localized dilatation of a segment of the aorta artery in its abdominal portion It affects 17 of men aged 65 years and older In the high-risk population male smokers aged 65-75 years its prevalence is estimated to be between 28 and 9 Mortality of ruptured AAAs is high 80 of deaths before hospitalization or perioperatively whereas mortality of scheduled procedures for unruptured AAAs is less than 5 AAA screening has been shown to significantly reduce the specific mortality rate in the medium and long term The French National Authority for Health HAS recommends targeted screening for AAA by ultrasound at the radiologist The target population is male smokers or former smokers aged 65 to 75 years as well as all persons aged 50 to 75 years with a family history of AAA Despite recommendations the rate of access to targeted screening appears low Ultrasound screening for AAA is a rapid noninvasive and reproducible test It relies primarily on the measurement of the maximum diameter of the abdominal aorta in cross-section It has been demonstrated that the learning of the ultrasound screening procedure for AAA is very fast and that the performance of non-radiologists trained in this procedure alone is similar to that of radiologists
In addition new ultra-portable ultrasound devices inexpensive and with validated performances have appeared on the market in the last few years making it possible to equip general practitioners GPs We propose a simplified care pathway for AAA screening by equipping GPs with an ultra-portable ultrasound scanner and by training them to perform the screening procedure which will be performed in the office or at the patients home during a usual consultation of general medicine Our hypothesis is that this new organization will allow better access to screening for the target population at a lower cost compared to the current screening method recommended by the HAS referral of the patient to the radiologist
In addition new ultra-portable ultrasound devices inexpensive and with validated performances have appeared on the market in the last few years making it possible to equip general practitioners GPs We propose a simplified care pathway for AAA screening by equipping GPs with an ultra-portable ultrasound scanner and by training them to perform the screening procedure which will be performed in the office or at the patients home during a usual consultation of general medicine Our hypothesis is that this new organization will allow better access to screening for the target population at a lower cost compared to the current screening method recommended by the HAS referral of the patient to the radiologist
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None