Evaluation of Inter-patient Variability Size of the Nasal Cavity, Based on CT Scans

Completed

• Conditions: Nasal Cavity

• Registration Number: NCT02879253
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

This study is part of the french research program ANR NEMRO "MICROROBOTIC NASAL ENDOSCOPY BY OPTICAL COHERENCE TOMOGRAPHY: IMPACT OF SMELL DEFICIENCY ON NEURODEGENERATIVE DISEASES." Recent studies have shown a strong correlation between the decrease in olfactory faculties of patients and the presence of neurodegenerative diseases.

This possible relationship has created a need to inspect in detail the area of the nasal cavity that houses the olfactory function.

Thus, the purpose of NEMRO project is developing a robot to explore olfactory slots of patients, with a view to extract images through non invasive imaging probe, and hoping to identify early signs of degeneration the olfactory tissue. The robot developed will thus be able to navigate in the nasal cavity of patients, and to break into the olfactory slots, which will host the imaging phase.

The purpose of this study is therefore to collect data on the usual path of instruments (endoscope, for example) in this area, and future potential pathway of the robot. This collection made from Computed Tomography (CT) scans will define the clinical geometry of the target area and provide precisely the dimensional constraints needed to build the NEMRO robot .

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-24
• Primary Completion: 2016-07-11
• Study Completion: 2016-07-11
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-25
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• men or women aged >18

Exclusion Criteria

• any pathology observed on the scan (sinusitis, cancer, previous surgery ...), that could interfere with the evaluated parameters, according to the medical expert

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Geometry of the nasal cavity and olfactory slots	at enrollment	Assesment of the geometry of the nasal cavity and olfactory slots, on previous available imaging. Composite primary outcome.
Width of the nasal cavity and olfactory slots	at enrollment	Distance measurements to evaluate the width of the nasal cavity and olfactory slots, on previous available imaging. Composite primary outcome.

Trial Locations

Locations (1)

CHU Besançon; 🇫🇷 Besançon, France