Design of an Augmented Reality System by Integration of CT Scan or MRI Data With Endoscopic Images for Video-assisted Endonasal Endoscopic Surgery

NCT04968561 | Unknown

• 1 other identifier: 2020 Becaud Nora
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Paranasal Sinus Diseases; Nasal Diseases; Lacrimal Apparatus Diseases

Keywords

Endoscopic sinus surgery; Augmented reality; Surgical Navigation system; Computer-assisted surgery; 3D reconstructions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

cohort 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients addmitted in the ENT and Cervico-Facial Surgery department of the Gabriel Montpied University Hospital in Clermont-Ferrand requiring endoscopic sinus surgery

You may qualify if:

• 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)

You may not qualify if:

• Patient under the age of 18

Sponsors & Collaborators

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

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Paranasal Sinus Diseases; Nose Diseases; Lacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Eye Diseases

Study Officials

• Justine Bécaud

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 20, 2021
• Study Start: November 2, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

FR (1)