Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
Overview[ - collapse ][ - ]
Purpose | The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation, impedance and neural response telemetry following cochlear implantation. |
---|---|
Condition | Hearing Loss |
Intervention | Device: Cochlear Implantation Drug: Cochlear Implantation+dexamethasone Drug: Cochlear Implantation+dexamethasone+hyaluronic acid |
Phase | Phase 2 |
Sponsor | University of Sao Paulo General Hospital |
Responsible Party | University of Sao Paulo General Hospital |
ClinicalTrials.gov Identifier | NCT01588925 |
First Received | April 24, 2012 |
Last Updated | March 22, 2013 |
Last verified | March 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | April 24, 2012 |
---|---|
Last Updated Date | March 22, 2013 |
Start Date | November 2011 |
Estimated Primary Completion Date | August 2013 |
Current Primary Outcome Measures | Hearing thresholds [Time Frame: within the first 6 months after surgery] [Designated as safety issue: Yes]Hearing thresholds will be measured by audiometry in the frequencies 125, 250, 500, 1000, 2000 and 4000 Hz in the preoperatory, 1 month, 3 months and 6 months after the surgery. |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation |
---|---|
Official Title | Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation |
Brief Summary | The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation, impedance and neural response telemetry following cochlear implantation. |
Detailed Description | Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the developmente of soft surgical techniques and pharmacological protection. In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Hearing Loss |
Intervention | Device: Cochlear Implantation Cochlear implantation using Hybrid L24 Implant Other Names: Hybrid L24 ImplantDrug: Cochlear Implantation+dexamethasone Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window Other Names:
Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array Other Names:
|
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
---|---|
Estimated Enrollment | 18 |
Estimated Completion Date | August 2013 |
Estimated Primary Completion Date | February 2013 |
Eligibility Criteria | Inclusion Criteria: - Adults (greater than 18 years old) with severe/profound, bilateral sensorineural hearing loss with indication of cochlear implantation. - 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: - Malformation or cochlear ossification - Developmental Disabilities |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Brazil |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01588925 |
---|---|
Other Study ID Numbers | 0297/11 |
Has Data Monitoring Committee | No |
Information Provided By | University of Sao Paulo General Hospital |
Study Sponsor | University of Sao Paulo General Hospital |
Collaborators | Not Provided |
Investigators | Principal Investigator: Bernardo F Ramos University of São Paulo General HospitalStudy Director: Rubens V Brito Neto University of São Paulo General Hospital |
Verification Date | March 2013 |
Locations[ + expand ][ + ]
University of São Paulo General Hospital | São Paulo, Brazil |
---|