Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

NCT01588925 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-10-03

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01588925 on ClinicalTrials.gov