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

Nasal Cavity Clinical Trial

— NEMROfentes3D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879253
• Other study ID #: P/2015/280
• Status: Completed
• Phase: N/A
• First received: August 10, 2016
• Last updated: August 9, 2017
• Start date: December 24, 2015
• Est. completion date: July 11, 2016

Study information

• Verified date: August 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 11, 2016
• Est. primary completion date: July 11, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasal Cavity

Locations

Country	Name	City	State
France	CHU Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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