Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590532
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
Sponsor:
None
Organization:
None
Study Overview
Official Title:
French Randomised Controlled Trial Investigating the Clinical and Cost-effectiveness Role of a Cloud-based Artificial Intelligent Image Fusion System to Guide Endovascular Aortic Aneurysm Repair and Aorto Iliac Revascularisation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADIOPROTEC
Brief Summary:
Evaluation of the clinical and cost-effectiveness of a mobile hybrid room compared with current practice without mobile hybrid room and imaging fusion guidance in a French multicentre clinical setting
The hypothesis is that the use of a mobile hybrid room with an automated artificial intelligent image fusion system would directly benefit patients health worker and health care system by reducing procedure time patient and staff exposure to radiation improve clinical success and reduce costs requested by a fixed imaging system installation and increasing the number of patients This will also improve the safety of these procedures for patient and staff when a conventional hybrid room is not available
The hypothesis is that the use of a mobile hybrid room with an automated artificial intelligent image fusion system would directly benefit patients health worker and health care system by reducing procedure time patient and staff exposure to radiation improve clinical success and reduce costs requested by a fixed imaging system installation and increasing the number of patients This will also improve the safety of these procedures for patient and staff when a conventional hybrid room is not available
Detailed Description:
Multi-centre patient- and observer-blinded two-armed parallel groups randomised controlled trial 7 French University hospital will include 350 patients presenting with AAA or aorto iliac occlusive disease suitable for endovascular treatment to either repair using standard X-ray fluoroscopy imaging alone the current reference standard or augmented with automated image fusion The study will be conducted in real-world clinical settings and will focus on multiple providers to demonstrate the effect in the wider healthcare system
The trial will be conducted in 7 centres in France over 24 months 350 patients will be recruited over a 18 month period with 3 months minimum follow-up Every vascular surgeon will be trained to use properly the fusion system and the first 5 patients of each center wont be included
Radiation parameters machine report passive dosimeters iodinated contrast technical and clinical success at 30-d and 3 months procedure time fluoro time and costs will be collected
The trial will be conducted in 7 centres in France over 24 months 350 patients will be recruited over a 18 month period with 3 months minimum follow-up Every vascular surgeon will be trained to use properly the fusion system and the first 5 patients of each center wont be included
Radiation parameters machine report passive dosimeters iodinated contrast technical and clinical success at 30-d and 3 months procedure time fluoro time and costs will be collected
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