NCT02905305

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

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

September 10, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

4.2 years

First QC Date

September 14, 2016

Last Update Submit

July 2, 2021

Conditions

Hearing Loss

Keywords

cochlear implantsDexamethasonecombined device

Outcome Measures

Primary Outcomes (2)

  • Surgical feedback

    Questionnaire used to obtain surgical feedback from experienced cochlear implant surgeons regarding the electrode design, and ease and effectiveness of surgery, when using the Combined Device as compared to the Contour Advance electrode

    During surgery

  • Safety of Combined Device

    Monitoring of device related adverse events that occur during the study period, to assess the preliminary safety of the Combined Device

    Monitoring over 24 months

Secondary Outcomes (2)

  • Electrode impedance

    Testing over 24 months

  • Electrically evoked compound action potential (ECAP)

    Testing over 24 months

Study Arms (2)

CA with dexamethasone base

EXPERIMENTAL

Contour Advance electrode with controlled dose of dexamethasone base

Device: Contour Advance electrode with controlled dose of dexamethasone base

Contour Advance

ACTIVE COMPARATOR

Standard Contour Advance electrode array

Device: Contour Advance electrode

Interventions

Contour Advance electrode with controlled dose of dexamethasone baseDEVICE

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.

CA with dexamethasone base
Contour Advance electrodeDEVICE

Standard Contour Advance electrode

Contour Advance

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Duration severe to profound hearing impairment in implanted ear of less than or equal to 30 years
  • Post-lingual hearing impairment defined as onset of hearing loss at greater than two years of age
  • Evidence of Pneumovax vaccination within three years of implantation date (for subjects to be implanted with the investigational device)

You may not qualify if:

  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or increased risk of infection (i.e. dysplastic cochlea), as confirmed by medical examination and imaging including MRI
  • Current use of grommets or evidence of tympanic membrane perforation
  • Known allergic reaction to dexamethasone or similar medicine
  • Diagnosis of Auditory Neuropathy
  • Active middle ear infection or history of middle ear infection within past two years
  • Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
  • Unwillingness or inability of the candidate to comply with all investigational requirements
  • Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The HEARing CRC

Melbourne, Victoria, 3053, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 19, 2016

Study Start

September 10, 2013

Primary Completion

November 6, 2017

Study Completion

March 15, 2018

Last Updated

July 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)