Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
NCT01588925 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2014-10-03
Summary
The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation
Conditions
Interventions
- DEVICE
-
Cochlear Implantation
Cochlear implantation using Hybrid L24 Implant
- DRUG
-
Cochlear Implantation+dexamethasone
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window
- DRUG
-
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
Sponsors & Collaborators
-
University of Sao Paulo General Hospital
lead OTHER
Principal Investigators
-
Bernardo F Ramos · University of São Paulo General Hospital
-
Rubens V Brito Neto · University of São Paulo General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-11-30
- Primary Completion
- 2013-02-28
- Completion
- 2014-01-31
Countries
- Brazil
Study Locations
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