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

June 26, 2020 updated by: Cochlear

Trans-impedance Matrix

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Routine patients undergoing a standard cochlear implantation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cochlear Implant Recipients
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over
Time Frame: at surgery, within one minute

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Investigators

  • Study Director: Bart Volckaerts, PhD, Cochlear

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2017

Primary Completion (Actual)

May 29, 2019

Study Completion (Actual)

May 29, 2019

Study Registration Dates

First Submitted

September 15, 2017

First Submitted That Met QC Criteria

September 22, 2017

First Posted (Actual)

September 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 26, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLTD5676

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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