Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

NCT ID: NCT01588925

Last Updated: 2014-10-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-01-31

Brief Summary

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The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation

Detailed Description

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Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development 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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

Cochlear Implantation

Group Type EXPERIMENTAL

Cochlear Implantation

Intervention Type DEVICE

Cochlear implantation using Hybrid L24 Implant

Dexamethasone

Cochlear implantation using topical dexamethasone

Group Type ACTIVE_COMPARATOR

Cochlear Implantation

Intervention Type DEVICE

Cochlear implantation using Hybrid L24 Implant

Cochlear Implantation+dexamethasone

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Cochlear Implantation

Intervention Type DEVICE

Cochlear implantation using Hybrid L24 Implant

Cochlear Implantation+dexamethasone+hyaluronic acid

Intervention Type DRUG

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

Intervention Type DEVICE

Cochlear Implantation+dexamethasone

Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Hybrid L24 Implant Hybrid L24 Implant Dexamethasone (4mg/ml) Hybrid L24 Implant Dexamethasone (4mg/ml) Hyaluronic acid (10mg/ml)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Brazil

Other Identifiers

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0297/11

Identifier Type: -

Identifier Source: org_study_id

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