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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03294681




Registration number
NCT03294681
Ethics application status
Date submitted
15/09/2017
Date registered
27/09/2017
Date last updated
29/06/2020

Titles & IDs
Public title
Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms
Scientific title
Trans-impedance Matrix
Secondary ID [1] 0 0
CLTD5676
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Objective measures with CSEP

Cochlear Implant Recipients -


Treatment: Devices: Objective measures with CSEP
Objective measures to be conducted with Custom SoundTM EP 5 software and the CP900 series sound processor in CI532 and CI512 Cochlear Implant recipients
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over
Timepoint [1] 0 0
at surgery, within one minute

Eligibility
Key inclusion criteria
* Candidate for cochlear implantation with the CI532 or CI512 devices
* 18 years of age or older at the time of enrolment
* Normal cochlea anatomy, established via pre-operative Computer Tomography
* Willingness to participate in and to comply with all requirements of the protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior cochlear implantation in the ear to be implanted
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
* Abnormal cochlear anatomy on pre-operative Computer Tomography or Magnetic Resonance Imaging
* Additional handicaps that would prevent participation in evaluations
* Pregnant and breast feeding women, prisoners, or anyone in custody
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/05/2019
Sample size
Target
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
HEARing CRC - Carlton
Recruitment postcode(s) [1] 0 0
- Carlton
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Erlangen
Country [2] 0 0
Germany
State/province [2] 0 0
Frankfurt am Main
Country [3] 0 0
Germany
State/province [3] 0 0
Kiel
Country [4] 0 0
Spain
State/province [4] 0 0
Las Palmas de Gran Canaria
Country [5] 0 0
Spain
State/province [5] 0 0
Pamplona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cochlear
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.
Trial website
https://clinicaltrials.gov/study/NCT03294681
Trial related presentations / publications
Hoppe U, Brademann G, Stover T, Ramos de Miguel A, Cowan R, Manrique M, Falcon-Gonzalez JC, Hey M, Baumann U, Huarte A, Liebscher T, Bennett C, English R, Neben N, Ramos Macias A. Evaluation of a Transimpedance Matrix Algorithm to Detect Anomalous Cochlear Implant Electrode Position. Audiol Neurootol. 2022;27(5):347-355. doi: 10.1159/000523784. Epub 2022 Mar 18.
Public notes

Contacts
Principal investigator
Name 0 0
Bart Volckaerts, PhD
Address 0 0
Cochlear
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03294681