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NCT02905305

Cochlear Implant With Anti-Inflammatory Agent

Completed NA Last updated 6 July 2021
What this trial tests

NA trial testing Contour Advance electrode with controlled dose of dexamethasone base in Hearing Loss in 48 participants. Completed in 15 March 2018.

Timeline
10 September 2013
Primary endpoint
6 November 2017
15 March 2018

Quick facts

Lead sponsorThe Hearing Cooperative Research Centre
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment48
Start date10 September 2013
Primary completion6 November 2017
Estimated completion15 March 2018
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

Sponsor

The Hearing Cooperative Research Centre

Who can join

Adults 18 to 85, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Local inner ear application of dexamethasone in cochlear implant models is safe for auditory neurons and increases the neuroprotective effect of chronic electrical stimulation.
    Scheper V, Hessler R, Hütten M, Wilk M, et al · · 2017 · cited 36× · PMID 28859106 · DOI 10.1371/journal.pone.0183820

Verify or expand the search:

Other recruiting trials for Hearing Loss

Currently open trials in the same condition.

Other The Hearing Cooperative Research Centre trials

Trials by the same sponsor.

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Data sources for this page

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