Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery: Comparative Study Between Perimodiolar and Lateral Wall Electrodes

DesconocidoClinicalTrials.gov

ID: NCT05079867Tipo: OBSERVATIONALInicio: 19 de jul de 2021Fin estimado: 19 de dic de 2023

Traducción no disponible, mostrando original

Resumen

Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.

Descripción detallada

Branches: * Perimodiolar (PM) * Lateral wall (PL) Follow up schedule: Preoperative visit POV1 (up to 90 days before D0) Intraoperative visit D0 (Surgery - Day 0) Follow-up visit 1 FUV1 (48 hours) Follow-up visit 2 FUV2 14 days Follow-up visit 3 FUV3 (4 weeks) Follow-up visit 4 FUV4 (3 months) Follow-up visit 5 FUV5 (6 months) Follow-up visit 6 FUV6 (12 months)

Elegibilidad

Edad mínima: 12 MonthsSexo: ALL

Criterios de inclusión

Patients to receive a Cochlear implant 12 Months of age or older at the time of incorporation Willingness to participate and comply with the requirements of the protocol Residual hearing better than 80 dBA at 500 Hz

Criterios de exclusión

Medical or pharmacological comorbid condition that contraindicates cochlear implantation.
Previous implantation in the ear of the new implant Ossification or any other cochlear abnormality that could prevent the complete insertion of the electrode guide Abnormal cochlear / neural anatomy on preoperative CT or MRI (excluding dilated vestibular aqueduct syndrome) Deafness due to lesions of the central auditory pathway. (Exclusion for evaluation of residual hearing) Diagnosis of Auditory Neuropathy Spectrum Disorder (Exclusion for evaluation of residual hearing) Active infection in the middle ear Chronic inflammatory processes in the middle ear Disabilities that could prevent participation in the evaluations Unrealistic expectations on the part of the participant regarding the possible benefits, risks and limitations inherent to the procedure or research protocol.
Surgical impossibility to follow the guidelines of the minimally traumatic technique.

Intervenciones

device

Cochlear implantation

Electrode surgically implanted in patient's cochlea to improve hearing

Ubicaciones

Hospital Italiano de Buenos Aires

Capital Federal, Buenos Aires, Argentina

Federico A Di Lella, MD PhD · federico.dilella@hospitalitaliano.org.ar · 54-11-49590200

RECRUITING

Patrocinadores

PrincipalHospital Italiano de Buenos Aires

Contactos

Federico A Di Lella, MD PhD

CONTACT

federico.dilella@hospitalitaliano.org.ar +5411 49590200

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