Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
NCT ID: NCT01588925
Last Updated: 2014-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2011-11-30
2014-01-31
Brief Summary
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Detailed Description
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In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
Cochlear Implantation
Cochlear Implantation
Cochlear implantation using Hybrid L24 Implant
Dexamethasone
Cochlear implantation using topical dexamethasone
Cochlear Implantation
Cochlear implantation using Hybrid L24 Implant
Cochlear Implantation+dexamethasone
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window
Dexamethasone+Hyaluronic acid
Cochlear implantation using topical dexamethasone associated with hyaluronic acid
Cochlear Implantation
Cochlear implantation using Hybrid L24 Implant
Cochlear Implantation+dexamethasone+hyaluronic acid
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array
Interventions
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Cochlear Implantation
Cochlear implantation using Hybrid L24 Implant
Cochlear Implantation+dexamethasone
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window
Cochlear Implantation+dexamethasone+hyaluronic acid
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hearing thresholds better than 80 dB in 125 Hz, 90 dB in 250Hz and 100 dB in 500, 1000, 2000, 3000 and 4000 Hz in at least 3 of these frequencies
Exclusion Criteria
* Developmental Disabilities
18 Years
70 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Bernardo F Ramos
Role: PRINCIPAL_INVESTIGATOR
University of São Paulo General Hospital
Rubens V Brito Neto
Role: STUDY_DIRECTOR
University of São Paulo General Hospital
Locations
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University of São Paulo General Hospital
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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0297/11
Identifier Type: -
Identifier Source: org_study_id
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