Imaging of Facial Neuritis | NCT03543384

Studies
Imaging of Facial Neuritis

NCT03543384

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jun 1, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Facial Neuritis

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2018Actual

Primary Completion Date

Feb 2019Estimated

Completion Date

Feb 2019Estimated

First Submitted Date

Feb 26, 2018

First Submission Date that Met QC Criteria

May 31, 2018

First Posted Date

Jun 1, 2018Actual

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

May 31, 2018

Last Update Posted Date

Jun 1, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence or absence of pathologic enhancement of the facial nerve on the symptomatological side of the T2 sequence (FIESTA-C)		1 hour after the realization of the MRI

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-80 years
Subject giving their consent for their participation
Patients with neuritis facial (neuritis group) who benefited, between 2009 and 2016, from an MRI of the internal auditory ducts, with gadolinous product injection and on the MRI 3 Tesla
Patients with a perception deafness, without neuritis sign (control group) who also benefited from an MRI with gadolinous product injection on the MRI 3T with the same protocol.

Exclusion Criteria:

- Refusal to participate in the study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with neuritis facial (neuritis group) who benefited, between 2009 and 2016, from an MRI of the internal auditory ducts, with gadolinous product injection and on the MRI 3 Tesla

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francis VEILLON, MD, PhD	Contact	33 3 88 12 78 65		Francis.veillon@chru-strasbourg.fr
Aïna VENKATASAMY, MD	Contact	33 3 88 12 78 65		aina.venkatasamy@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Francis VEILLON, MD, PhD	University Hospital, Strasbourg, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service Imagerie 1	Recruiting	Strasbourg		67098	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

Condition Browse Module

MeSH Terms

ID	Term
D005155	Facial Nerve Diseases

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided