Status:
RECRUITING
Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Sensorineural Hearing Loss
Fibrosis
Eligibility:
All Genders
18-120 years
Brief Summary
Cochlear fibrosis development can compromise the success and the outcomes of the cochlear implantation (CI) thus affecting the quality of life of the implanted patient. Correlating the results of the ...
Detailed Description
Fibrosis tissue growth after the CI is an inflammatory reaction to a foreign body occurring around the electrode array. It is considered responsible for a larger current diffusion, less precise stimul...
Eligibility Criteria
Inclusion
- Group with long-term implantation:
- Age18 years or older
- Affiliation to the French social security
- Signed and dated informed consent form
- Users of uni or bilateral cochlear implants for more than 6 months (CI24CA, CI422, CI512, CI522, CI532, CI612; CI622; CI632), in primo-implantation or reimplantation, with more than 18 electrodes active
- Postoperation CBCT imaging results available
- Recently-implanted group:
- Age18 years or older
- Affiliation to the French social security
- Signed and dated informed consent form
- Indication for CI622 or CI632 cochlear implants
- Postoperation CBCT imaging results available
Exclusion
- Vulnerable individuals (minors, adults protected in accordance to the French Public Health code, patients deprived of liberty by court decision)
- Daily usage of the cochlear implant for less than 4 hours or weekly usage for less than 5 days
- Failure or disfunction of the cochlear implant
Key Trial Info
Start Date :
January 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 12 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05402969
Start Date
January 12 2023
End Date
January 12 2025
Last Update
May 29 2024
Active Locations (1)
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1
University Hospital Montpellier
Montpellier, France