Actively Recruiting
Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools
Led by University Hospital, Montpellier · Updated on 2024-05-29
180
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Transimpedance Matrix (TIM) measurements to the implant electrode location determined by the Cone Beam Computer Tomography (CBCT), this study aims to identify a range of TIM profiles within the implanted population, certain profiles suggesting the growth of the fibrosis tissue in cochlea
CONDITIONS
Official Title
Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 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) with more than 18 electrodes active (long-term group)
- Postoperative CBCT imaging results available (long-term group)
- Indication for CI622 or CI632 cochlear implants (recently implanted group)
- Postoperative CBCT imaging results available (recently implanted group)
You will not qualify if you...
- Vulnerable individuals (minors, adults protected under the French Public Health code, or patients deprived of liberty by court decision)
- Daily cochlear implant use less than 4 hours or use less than 5 days per week
- Cochlear implant failure or dysfunction
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Montpellier
Montpellier, France
Actively Recruiting
Research Team
V
Venail Frederic, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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