Prediciton of the Round Window Visibility Through Posteri... | NCT03589209

Studies
Prediciton of the Round Window Visibility Through Posterior Tympanotomy by CT Scan Analysis

NCT03589209

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jul 19, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Tympanostomy Tube Insertion

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

Jun 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

Jun 1, 2018Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Jul 4, 2018

First Submission Date that Met QC Criteria

Jul 16, 2018

First Posted Date

Jul 17, 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

Jul 17, 2018

Last Update Posted Date

Jul 19, 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

It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery.

The primary purpose of the study is to define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window. Define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window.

The secondary purpose is to validate the investigator's scanner reading protocol for a prospective study.

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of the correlation between preoperative CT measurements and the visibility of the round window observed intraoperatively (based on the operative records)	Analysis of patient records (operative reports and preoperative CT-scan) from patients who underwent cochlear implantation between 01/01/2010 and 01/03/2018.	1 day after cochlear implantation surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged subject from 9 months and over
Implanted cochlear subject in the ENT department of Strasbourg between 1st January 2010 and 1st March 2018
Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research.

Exclusion Criteria:

Refusal of the patient to participate in the study
CROP does not make it possible to evaluate the visibility of the FR
Preoperative or uninterpretable scanner
Major anatomical malformation
Subject under the protection of justice
Subject under guardianship or curatorship

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Implanted cochlear subject in the ENT department of Strasbourg between 1st January 2010 and 1st March 2018

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anne CHARPIOT, MD, PhD	Contact	33 3 88 12 76 49		anne.charpiot@chru-strasbourg.fr
Carine EYERMANN, MD	Contact	33 3 88 12 76 49		Carine.eyermann@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Anne CHARPIOT, MD, PhD	University Hospital, Strasbourg, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service D'Orl Et de Chirurgie Cervico-Faciale	Recruiting	Strasbourg		67091	France