Lacrimal Apparatus Diseases Clinical Trial
— NORAOfficial title:
Design of an Augmented Reality System by Integration of CT Scan or MRI Data With Endoscopic Images for Video-assisted Endonasal Endoscopic Surgery
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - Patient under the age of 18 |
Country | Name | City | State |
---|---|---|---|
France | CHU clermont-ferrand | Clermont-Ferrand |
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 |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT03436576 -
Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye
|
Phase 3 | |
Completed |
NCT02386774 -
Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa
|
N/A | |
Completed |
NCT06428266 -
Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction
|
N/A | |
Completed |
NCT00706251 -
Follow up of Nasolacrimal Intubation in Adults
|
N/A | |
Completed |
NCT01826734 -
Analysis of 86 Dacryoliths at the University Hospital Ostrava
|
N/A | |
Completed |
NCT04240431 -
Level of Lacrimal Passage Obstruction
|
||
Completed |
NCT03706443 -
Tear Lipid Layer Thickness Changes With Use of Emollient and Non-Emollient Eye Drops
|
N/A |