Status:
UNKNOWN
Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery
Lead Sponsor:
Hospital Italiano de Buenos Aires
Conditions:
Sensorineural Hearing Loss
Cochlear Implant
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
Hearing is the ability to perceive sounds through the ear. If the transmission of sound is defective, the person suffers some degree of hearing loss. Cochlear Implants (CI) provide partial hearing by ...
Detailed Description
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 electro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03374514
Start Date
August 9 2017
End Date
November 1 2018
Last Update
December 29 2017
Active Locations (1)
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1
HIBA
CABA, Buenos Aires, Argentina