NCT03950375

Brief Summary

The aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

May 13, 2019

Last Update Submit

June 12, 2020

Conditions

Cochlear Implantation

Keywords

Sensorineural Hearing LossRound Windowear surgeryCochlear implantation

Outcome Measures

Primary Outcomes (1)

  • peroperative round window exposure

    peroperative round window exposure evaluated according to St Thomas' Hospital classification: * visible (classes I and II) and not visible (class III) * easily visible (classes I and IIa) and not easily visible (class IIb and III)

    Day 0

Study Arms (1)

cochlear implantation

"cochlear implantation" group : patients undergoing cochlear implantation between December 2018 and June 2019 in the ENT service of Reims universitary hospital.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cochlear implantation

You may qualify if:

  • patients who agree to participate in the study
  • patients who had preoperative temporal bone CT scan

You may not qualify if:

  • temporal bone malformation on temporal bone CT scan or MRI
  • chronic otitis media (except simple middle ear effusion)
  • middle ear surgery antecedent
  • cochlear implant in the context of a reimplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 15, 2019

Study Start

December 18, 2018

Primary Completion

April 24, 2019

Study Completion

April 24, 2019

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

FR(1)