NCT04968561|Unknown
Design of an Augmented Reality System by Integration of CT Scan or MRI Data With Endoscopic Images for Video-assisted Endonasal Endoscopic Surgery
NORA
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NORA
Sponsor study identifier
observational
40
1 country
1
Study Start
November 2, 2020
Actual (reported)Primary Completion
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2, 2020
Actual (reported)July 5, 2021
Actual (reported)July 20, 2021
Actual (reported)September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Adult patients * Admitted in the ENT and Cervico-Facial Surgery department of the Gabriel Montpied University Hospital in Clermont-Ferrand. * From November 2020 to October 2021, * Requiring endoscopic sinus surgery * With good quality imaging (CT scan and/or MRI)
Adult patients addmitted in the ENT and Cervico-Facial Surgery department of the Gabriel Montpied University Hospital in Clermont-Ferrand requiring endoscopic sinus surgery
CHU clermont-ferrand
Clermont-Ferrand, France
Justine Bécaud
University Hospital, Clermont-Ferrand
First Submitted
July 5, 2021
First Posted
July 20, 2021
Study Start
November 2, 2020
Actual (reported)Primary Completion
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Level of Lacrimal Passage Obstruction
Contact the study team to confirm eligibility.
Study Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 20, 2021
Record last verified: 2021-07
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