Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2025-12-16 @ 5:51 PM
Study NCT ID:
NCT04714268
Status:
None
Last Update Posted:
2021-01-19 00:00:00
First Post:
2021-01-15 00:00:00
Brief Title:
Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation
Sponsor:
Therenva
Organization:
Therenva
Study Overview
Official Title:
Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation
Status:
None
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
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:
COM-ENDO
Brief Summary:
Minimally invasive endovascular interventions are increasingly replacing conventional surgeries, and have become the therapeutic benchmark for a large number of pathologies thanks in particular to advances in image-guided therapy. Therenva offers a comprehensive and consistent lightweight navigation solution (EndoNaut®) for endovascular procedures. This navigation station makes it possible to secure and guide the interventional gesture by providing relevant information extracted during the preoperative phase. This information is rendered in augmented reality using artificial intelligence algorithms and digital simulation. This alternative solution to a hybrid room, but which offers equivalent functionality, is compatible with all operating rooms, regardless of the interventional environment. Benefits of imaging fusion remain to be assessed on a larger scale. The aim of this multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.
Detailed Description:
Minimally invasive endovascular interventions are increasingly replacing conventional surgeries and have become the therapeutic benchmark for a large number of pathologies thanks in particular to advances in image-guided therapy Therenva offers a comprehensive and consistent lightweight navigation solution EndoNaut for endovascular procedures This navigation station makes it possible to secure and guide the interventional gesture by providing relevant information extracted during the preoperative phase This information is rendered in augmented reality using artificial intelligence algorithms and digital simulation This alternative solution to a hybrid room but which offers equivalent functionality is compatible with all operating rooms regardless of the interventional environment Benefits of imaging fusion remain to be assessed on a larger scale The aim of this multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient reduction in irradiation and the volume of contrast product as well as for the nursing staff reduction irradiation compared to procedures performed without EndoNaut
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