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NCT02905305
Cochlear Implant With Anti-Inflammatory Agent
NA trial testing Contour Advance electrode with controlled dose of dexamethasone base in Hearing Loss in 48 participants. Completed in 15 March 2018.
6 November 2017
Quick facts
| Lead sponsor | The Hearing Cooperative Research Centre |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 10 September 2013 |
| Primary completion | 6 November 2017 |
| Estimated completion | 15 March 2018 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Contour Advance electrode with controlled dose of dexamethasone base
- Contour Advance electrode
Conditions studied
- Hearing Loss — all drugs for Hearing Loss →
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):
-
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:
- PubMed search for NCT02905305
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07218913 — Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III · Phase 1 · recruiting
- NCT07414329 — Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit · NA · recruiting
- NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms · NA · recruiting
Other The Hearing Cooperative Research Centre trials
Trials by the same sponsor.
- NCT02746172 — Clinical Metrics for Assessing Cochlear Implant Recipient MAPs · NA · completed
- NCT02765386 — Optimisation of Hybrid Fittings for Cochlear Implant Recipients · NA · terminated
- NCT02879539 — Cochlear Implant Low Power Strategy · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02905305 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Hearing Cooperative Research Centre
- Last refreshed: 6 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02905305.
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