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

NCT ID: NCT03589209

Last Updated: 2018-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-06-30

Brief Summary

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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

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Conditions

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Tympanostomy Tube Insertion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne CHARPIOT, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Strasbourg, France

Locations

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Service D'Orl Et de Chirurgie Cervico-Faciale

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Anne CHARPIOT, MD, PhD

Role: CONTACT

33 3 88 12 76 49

Carine EYERMANN, MD

Role: CONTACT

33 3 88 12 76 49

Facility Contacts

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Anne CHARPIOT, MD, PhD

Role: primary

33 3 88 12 76 49

Carine EYERMANN, MD

Role: backup

33 3 88 12 76 49

Other Identifiers

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7052

Identifier Type: -

Identifier Source: org_study_id

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