NCT04711538

Brief Summary

cochlear implant is a well accepted treatment to profound sensorineural hearing loss. Imaging provides essential information about anatomical Variants that could be riskyand should be considered by cochlear implant surgeon and the aim of the study:-

  • Identify inner ear congenital and acquired abnormalities.
  • Identify cochlear nerve anomalies.
  • Detect temporal bone abnormalities that require surgical modification by cochlear implant surgeon.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

January 13, 2021

Last Update Submit

January 13, 2021

Conditions

Cochlear Implant

Outcome Measures

Primary Outcomes (1)

  • identification inner ear congenital and acquired abnormalities

    detect role of MRI and CT in identification of cochlear nerve anomlies,detect temporal bone abnormalities that require surgical modification by cochlear implant surgeon.

    immediately after end of imaging and diagnosis

Interventions

MRIDEVICE

imaging inner ear and petrous bone of the candidate by MRI and CT

Also known as: CT imaging

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who suffering from deep to profound sensorineural hearing loss( inculde any age,both genders)

You may qualify if:

  • Age, any age will included
  • Gender, both genders will be included.
  • Patient full filled criteria for CI including audiological \& phoniatric criteria

You may not qualify if:

  • Patient who did not fulfill the criteria for indicating CI surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Sohag Governorate, 82524, Egypt

RECRUITING

Related Publications (3)

  • Alam-Eldeen MH, Rashad UM, Ali AHA. Radiological requirements for surgical planning in cochlear implant candidates. Indian J Radiol Imaging. 2017 Jul-Sep;27(3):274-281. doi: 10.4103/ijri.IJRI_55_17.

    PMID: 29089672BACKGROUND

  • Joshi VM, Navlekar SK, Kishore GR, Reddy KJ, Kumar EC. CT and MR imaging of the inner ear and brain in children with congenital sensorineural hearing loss. Radiographics. 2012 May-Jun;32(3):683-98. doi: 10.1148/rg.323115073.

    PMID: 22582354RESULT

  • Marsot-Dupuch K, Meyer B. Cochlear implant assessment: imaging issues. Eur J Radiol. 2001 Nov;40(2):119-32. doi: 10.1016/s0720-048x(01)00380-1.

    PMID: 11704359RESULT

MeSH Terms

Interventions

Postmortem Imaging

Intervention Hierarchy (Ancestors)

AutopsyDiagnostic Techniques and ProceduresDiagnosisDiagnostic ImagingInvestigative Techniques

Study Officials

  • Mohammed H Alam-Eldeen, AP

    Sohag University

    STUDY DIRECTOR

  • Ramadan H Hashem, Prof

    Sohag University

    STUDY CHAIR

Central Study Contacts

Marwa H Elhadad, AI

CONTACT

01122029281marwa.elhadad@med.sohag.edu.eg

Mohammed T Mahmoud, Prof

CONTACT

01064469957mthalewaig@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

February 1, 2021

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

January 15, 2021

Record last verified: 2021-01

Locations

EG(1)