Evaluation of Inter-patient Variability Size of the Nasal... | NCT02879253

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

NCT02879253

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Aug 10, 2017Actual

Enrollment

36Actual

Phase

Not provided

Conditions

Nasal Cavity

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 24, 2015Actual

Primary Completion Date

Jul 11, 2016Actual

Completion Date

Jul 11, 2016Actual

First Submitted Date

Aug 10, 2016

First Submission Date that Met QC Criteria

Aug 22, 2016

First Posted Date

Aug 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2017

Last Update Posted Date

Aug 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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 ...).

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU Besançon		Besançon		25000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided