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Search / Trial NCT03374514

Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery

Launched by HOSPITAL ITALIANO DE BUENOS AIRES · Dec 14, 2017

Trial Information

Current as of August 28, 2025

Unknown status

Keywords

Corticosteroids Electric Impedance

ClinConnect Summary

Hypothesis The use of topical dexamethasone in a single dose applied to the tympanic cavity during cochlear implant surgery modifies the capacitive component of the electrical impedance of the electrodes in the cochlea during the first days of the postoperative period.

goals Primary objective To assess whether the use of topical dexamethasone in a single dose applied to the tympanic cavity (middle ear) during cochlear implant surgery, prior to the insertion of the electrode array in the cochlea modifies the capacitive component of the electrical impedance of the cochlear implant. electrode...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients who are candidates to receive a uni or bilateral cochlear implant with diagnosis of severe neurosensory hearing loss.
  • Ages between 12 months and 85 years.
  • Evaluation of internal ear anatomy performed by tomography and resonance magnetic, where normal cochlea and internal auditory canals are evidenced normal.
  • Patients in which any implant of the Cochlear company is used: CI512, CI522 or CI532 with chipset CIC4 or higher.
  • Complete insertion of electrodes through round window, round window enlarged or cochleostomy, via posterior tympanotomy using the technique universally known as "minimally traumatic surgery"
  • Exclusion Criteria:
  • Refusal to participate in the protocol or to informed consent
  • Intra-surgical gusher (see below, section "definitions").
  • Contraindication to receive dexamethasone
  • Medical, imaging, psychological or social contraindications to receive a cochlear implant
  • Surgical or anesthetic contraindications for cochlear implant surgery.

About Hospital Italiano De Buenos Aires

Hospital Italiano de Buenos Aires is a leading healthcare institution dedicated to advancing medical research and patient care. Renowned for its commitment to clinical excellence and innovation, the hospital actively participates in a range of clinical trials aimed at developing new treatment modalities and improving healthcare outcomes. With a multidisciplinary team of experienced healthcare professionals, Hospital Italiano combines cutting-edge technology with a patient-centered approach, ensuring the highest standards of safety and efficacy in all research endeavors. As a trusted sponsor, the hospital is committed to contributing to the global medical community through rigorous scientific investigations and collaboration with various stakeholders.

Locations

Caba, Buenos Aires, Argentina

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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