Evaluation of Inter-patient Variability Size of the Nasal Cavity, Based on CT Scans (NEMROfentes3D)

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 .

Study Overview

• Status: Completed
• Conditions: Nasal Cavity

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • CHU Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

CT scans of men and women > 18 years will be observed. Age selected corresponds to a period where the nasal cavity is completely formed, with no more structural and morphological changes due to the growth of the individual in the development phase; regarding sex study subjects, an equal distribution between men and women is required wherever possible.

Will be excluded images suggesting a pathology that could interfere with the target parameters of the study in the area, according to the opinion of the maxillofacial surgeon in charge of the collection (sinusitis, cancer, previous surgery ...).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2015
• Primary Completion (Actual): July 11, 2016
• Study Completion (Actual): July 11, 2016

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: P/2015/280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO