NCT02852330

Brief Summary

Collection of normative voltage tomography data during and/or immediately after electrode insertion into the cochlea using Surgical Assistant (SA16) research software and postoperatively at activation, three and twelve months post-activation with CS19 research software in adults who are receiving a Cochlear Nucleus CI512, CI422, CI522 or CI532 cochlear implant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

June 3, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

May 25, 2021

Completed
Last Updated

February 10, 2025

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

June 3, 2016

Results QC Date

February 19, 2021

Last Update Submit

January 27, 2025

Conditions

Hearing Loss

Keywords

Voltage tomography

Outcome Measures

Primary Outcomes (1)

  • Normative Voltage Tomography Data

    Gather normative voltage tomography data for retrospective analysis. After insertion of the electrode array, TIM measurements will be taken from each subject using the cochlear implant system and Surgical Assistant Research Tool software. A Tip Foldover (TFO) in the software and x-rays will be used to identify any occurrence of a tip foldover.

    intraoperatively during and/or immediately after electrode insertion into the cochlea, with a measurement time of approximately 10 minutes.

Study Arms (1)

Voltage tomography

EXPERIMENTAL

Voltage tomography measurements will be made with the SA16 research software and CS19 (1.6.2) software during and/or immediately after electrode insertion during cochlear implantation and at scheduled post-operative clinical visits.

Device: SA16 research softwareDevice: CS19 (1.6.2)

Interventions

SA16 research softwareDEVICE

Software for measurement of voltage tomography intraoperatively.

Voltage tomography
CS19 (1.6.2)DEVICE

Software for measurement of voltage tomography post-operatively.

Voltage tomography

Eligibility Criteria

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

You may qualify if:

  • Meet current cochlear implant indications at the implanting centre for a Cochlear Nucleus CI512, CI422, CI522 or CI532 cochlear implant
  • Aged 18 years and older at the time of implantation.

You may not qualify if:

  • Recipient of a Nucleus 24 ABI device
  • Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
  • Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination.
  • Unwillingness or inability of the candidate to comply with all investigational requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Hearing Cooperative Research Centre

Carlton, Victoria, 3053, Australia

Location

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, 30002, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Bernadette Pickering
Organization
Cochlear
bpickering@cochlear.com
+61296115909

Study Officials

  • Robert Cowan

    The HEARing CRC

    PRINCIPAL INVESTIGATOR

  • Robert Briggs

    The Royal Victorian Eye and Ear Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

August 2, 2016

Study Start

July 10, 2017

Primary Completion

October 10, 2018

Study Completion

October 10, 2018

Last Updated

February 10, 2025

Results First Posted

May 25, 2021

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)