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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04714268
Other study ID # 002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 1, 2022

Study information

Verified date January 2021
Source Therenva
Contact Florent Lalys, PhD
Phone +33789833846
Email florent.lalys@therenva.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this retrospective, 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Unilateral or bilateral aorto-iliac or iliac aneurysm/stenosis - Suitable for endovascular repair - Major patients - Patients not opposed to their participation in the study Exclusion Criteria: - Patients requiring conventional surgical revascularization.

Study Design


Intervention

Procedure:
Aorto-iliac endovascular procedure
Percutaneous procedure with stent placement

Locations

Country Name City State
France CHU Rennes Rennes

Sponsors (6)

Lead Sponsor Collaborator
Therenva Dijon University Hospital, Douai hospital, Polyclinique Bordeaux Nord Aquitaine, Rennes University Hospital, University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Volume of contrast product used during the routine care procedure (ml) Volume are reported in mL At enrollment
Primary Irradiation parameters: evaluation of the Fluoroscopy duration (min) Parameter given by the X-ray imaging device At enrollment
Primary Irradiation parameters: dose-area quantification (mGy/m2) Parameter given by the X-ray imaging device At enrollment
Primary Irradiation parameters: measurement of air Kerma (mGy) Parameter given by the X-ray imaging device At enrollment
Secondary Procedure time (min) Total procedure time At enrollment
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