Imaging Perilymphatic Fistulas After Barotrauma | NCT03543293

Studies
Imaging Perilymphatic Fistulas After Barotrauma

NCT03543293

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jun 1, 2018Actual

Enrollment

101Estimated

Phase

Not provided

Conditions

Perilymphatic Fistulas

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

Description Module

Brief Summary

Our objective is to validate the CT / MRI combination of non-injected rock for the rapid positive diagnosis of perilymphatic fistulas.

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

101Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of perilymphatic fistula		1 hour after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than or equal to 18
Clinical suspicion of perilymphatic fistula
Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal)

Exclusion Criteria:

- Refusal of the patient to participate in the study

Accepts Healthy Volunteers

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

Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal)

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
D014717	Vertigo
D014012	Tinnitus

Ancestor Terms

ID	Term
D015837	Vestibular Diseases
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided