Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms

Hearing Loss Clinical Trial

Official title:

Trans-impedance Matrix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294681
• Other study ID #: CLTD5676
• Status: Completed
• Start date: October 3, 2017
• Est. completion date: May 29, 2019

Study information

• Verified date: June 2020
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 29, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• 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

Locations

Country	Name	City	State
Australia	HEARing CRC	Carlton
Germany	Hals-Nasen-Ohren-Klinik Universitätsklinikum Erlangen	Erlangen
Germany	Klinik für Hals-, Nasen-, Ohrenheilkunde Universitätsklinikum Frankfurt Goethe-Universität	Frankfurt am Main
Germany	Universitätsklinikum Schleswig- Holstein - Campus Kiel Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie	Kiel
Spain	Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas de Gran Canaria
Spain	Clinica Universitaria de Navarra	Pamplona

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Countries where clinical trial is conducted

Australia,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over	Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery.; Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm.	at surgery, within one minute