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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04968561
Other study ID # 2020 Becaud Nora
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2, 2020
Est. completion date October 2021

Study information

Verified date July 2021
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone 334.73.754.963
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The gold standard surgical treatment for benign nasosinus pathologies is endoscopic surgery. This surgery has experienced considerable growth over the last 30 years. Nevertheless, these techniques can potentially lead to serious complications, with risks of damaging adjacent structures (orbit, optic nerve, meninge or internal carotid artery). Therefore, improving the safety of these procedures is a fundamental objective. Recently, computer-assisted surgery, allowing endonasal navigation, has emerged. It appears to be an asset for the patient, limiting complications and morbidity, and for the surgeon, improving his comfort and reducing his mental workload. The major pitfall of the current technique is the loss of localisation reliability during the intervention due to the registration process and the presence of two screens (to locate the object on the endoscopic image and on the scan) We would like to propose solutions to these limitations using a device based on augmented reality and 3D reconstructions. It would guide the gesture in endonasal endoscopic surgery by displaying high-risk areas and surgical landmarks in a reliable and precise way.


Description:

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Study Design


Locations

Country Name City State
France CHU clermont-ferrand Clermont-Ferrand

Sponsors (6)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Audition Conseil, Bourse Année-Recherche par l'Agence Régionale de Santé Auvergne Rhone Alpes pour Mme Luce COMPAGNONE pour l'année 2020-2021, CHU Clermont-Ferrand (Appel d'offre Interne), Collin medical, Institut Pascal (CNRS 6602/ Université Clermont Auvergne / SIGMA), équipe EnCoV

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Target registration error The feasibility of integrating medical imaging data with endoscopic images will be assessed by the accuracy of the registration obtained, called TRE (Target Registration Error). This is a standard evaluation methodology of a registration between modalities. day 1
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