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Cochlear Implant With Anti-Inflammatory Agent

NCT02905305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-07-06

No results posted yet for this study

Summary

In an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. This study aims to assess the ease and effectiveness of such an electrode design, and to assess the preliminary safety of use of such a device in the post-operative period. This study is a first-time-in-human study of the investigational device.

In the first instance, the aim of the current investigation is to obtain first experience in use of a Combined Device in the adult clinical population, and to assess tools and techniques that may be considered in future clinical studies of similar devices.

Conditions

Interventions

DEVICE

Contour Advance electrode with controlled dose of dexamethasone base

The Combined Device consists of a standard cochlear implant receiver-stimulator coupled to a Contour Advance electrode loaded with a controlled dose of dexamethasone base.

DEVICE

Contour Advance electrode

Standard Contour Advance electrode

Sponsors & Collaborators

  • Cochlear

    collaborator INDUSTRY

  • Royal Victoria Eye and Ear Hospital

    collaborator OTHER_GOV

  • Royal Prince Alfred Hospital, Sydney, Australia

    collaborator OTHER

  • St Vincent's Hospital Melbourne

    collaborator OTHER

  • Westmead Hospital, New South Wales

    collaborator UNKNOWN

  • The Hearing Cooperative Research Centre

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-10
Primary Completion
2017-11-06
Completion
2018-03-15

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT02905305 on ClinicalTrials.gov