Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools: Comparison With Postoperative Cone Beam CT

Status: Recruiting

Location: See location...

Intervention Type: Procedure

Study Type: Observational

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 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

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 120

Healthy Volunteers: f

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⁃ 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

Locations

Other Locations

France

University Hospital Montpellier

RECRUITING

Montpellier

Contact Information

Primary

Venail Frederic, MD, PhD

f-venail@chu-montpellier.fr

+33467336890

Time Frame

Start Date: 2023-01-12

Estimated Completion Date: 2025-01-12

Participants

Target number of participants: 180

Treatments

Patients with long-term implantation

Patients undergone CI more than 6 months ago. After the study is presented to the patient and the egligibility criterias are verified, the patient is proposed to sign a consent form (visit 0). Once the consent form is signed, the visit 1 is scheduled (0 to 90 days after the visit 0). During the visit 1 TIM measurements are performed, including depth sounding and spectroscopy, and adversed affects if any are collected.

Recently implanted patients

Patients enrolled at their pre-op appointments (visit 0 - egligibilty criterias are verified and the consent collected). Visit 1 (0 to 90 days after visit 0) is a surgery. TIM measurements, icluding deep sound and spectroscopy, are performed after the CI and all adverse events are noted. CBCT is routinely done the next day after CI. TIM measurements (as well as adverse event collection) are repeated during visits 2, 3, 4, 5 and 6 (appoitments 15 days, 1, 2, 3 and 6 months after the surgery).

Related Therapeutic Areas

Hearing Loss

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Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools: Comparison With Postoperative Cone Beam CT

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