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

Preoperative CT Scan Analysis to Predict Perioperative Round Window Visibility Through the Posterior Tympanotoy in Cochlear Implant Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Tympanostomy Tube Insertion

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service D'Orl Et de Chirurgie Cervico-Faciale
    • Contact: Carine EYERMANN, MD; Phone Number: 33 3 88 12 76 49; Email: Carine.eyermann@chru-strasbourg.fr
    • Sub-Investigator: Carine EYERMANN, MD
    • Sub-Investigator: Sophie RIEHM, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Study Director: Anne CHARPIOT, MD, PhD, University Hospital, Strasbourg, france

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Round window visibility; Cochlear implantation
• Other Study ID Numbers: 7052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No