Fibrosis Clinical Trial
— TIMAGINGOfficial title:
Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools: Comparison With Postoperative Cone Beam CT
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
Status | Recruiting |
Enrollment | 180 |
Est. completion date | January 12, 2025 |
Est. primary completion date | July 12, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Inclusion Criteria: 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TIM profiles in patients with long-term implantation | Comparison of TIM profiles of patients with ST electrode position versus patients with SV electrode dislocateon in the long-term implantation group | Visit 1 (0 to 90 days after inclusion) | |
Primary | TIM profiles time dynamics in the recently implanted patients | Assessment of the TIM profile changes with time and depending on electrode scala position in newly-implanted patients | Visit 1 - surgery (0 to 90 days after inclusion), visit 3, 4, 5, 6 (1, 2, 3 and 6 months after surgery) | |
Secondary | TIM profiles depending on electrode array and inner ear access | Comparison of the TIM profiles depending on the electrode array type and inner ear access | Visit 1 (0 to 90 days after inclusion) | |
Secondary | Depth sounding versus the distance electrode - spiral ganglion | Correlation of the depth sounding measures with the electrode-spiral ganglion distance assesed through CBCT imaging | Visit 1 (0 to 90 days after inclusion) | |
Secondary | Spectroscopy of the specific electrode insertion zones | Comparison of the spectroscopy measures in the specific zones prone to electrode insertion damages (180° turn and basal part) between groups with ST electrode positioning and SV electrode dislocation | Visit 1 (0 to 90 days after inclusion) |
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