NCT01588925

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 3, 2014

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

April 24, 2012

Last Update Submit

October 2, 2014

Conditions

Hearing Loss

Keywords

Cochlear implantationDexamethasoneAcid, Hyaluronic

Outcome Measures

Primary Outcomes (1)

  • Hearing thresholds

    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.

    within the first 6 months after surgery

Study Arms (3)

Control group

EXPERIMENTAL

Cochlear Implantation

Device: Cochlear Implantation

Dexamethasone

ACTIVE COMPARATOR

Cochlear implantation using topical dexamethasone

Device: Cochlear ImplantationDrug: Cochlear Implantation+dexamethasone

Dexamethasone+Hyaluronic acid

ACTIVE COMPARATOR

Cochlear implantation using topical dexamethasone associated with hyaluronic acid

Device: Cochlear ImplantationDrug: Cochlear Implantation+dexamethasone+hyaluronic acid

Interventions

Cochlear ImplantationDEVICE

Cochlear implantation using Hybrid L24 Implant

Also known as: Hybrid L24 Implant
Control groupDexamethasoneDexamethasone+Hyaluronic acid
Cochlear Implantation+dexamethasoneDRUG

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

Also known as: Hybrid L24 Implant, Dexamethasone (4mg/ml)
Dexamethasone
Cochlear Implantation+dexamethasone+hyaluronic acidDRUG

Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array

Also known as: Hybrid L24 Implant, Dexamethasone (4mg/ml), Hyaluronic acid (10mg/ml)
Dexamethasone+Hyaluronic acid

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Malformation or cochlear ossification
  • Developmental Disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Hearing LossHeartburn

Interventions

Cochlear ImplantationDexamethasoneHyaluronic Acid

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Otologic Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Bernardo F Ramos

    University of São Paulo General Hospital

    PRINCIPAL INVESTIGATOR

  • Rubens V Brito Neto

    University of São Paulo General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2012

First Posted

May 1, 2012

Study Start

November 1, 2011

Primary Completion

February 1, 2013

Study Completion

January 1, 2014

Last Updated

October 3, 2014

Record last verified: 2013-03

Locations

BR(1)