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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294681
Recruitment Status : Completed
First Posted : September 27, 2017
Results First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Cochlear

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

Condition or disease Intervention/treatment
Hearing Loss Device: Objective measures with CSEP

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Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trans-impedance Matrix
Actual Study Start Date : October 3, 2017
Actual Primary Completion Date : May 29, 2019
Actual Study Completion Date : May 29, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Routine patients undergoing a standard cochlear implantation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294681


Locations
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Australia
HEARing CRC
Carlton, Australia
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, Germany
Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
Sponsors and Collaborators
Cochlear
Investigators
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Study Director: Bart Volckaerts, PhD Cochlear
  Study Documents (Full-Text)

Documents provided by Cochlear:
Study Protocol  [PDF] May 14, 2018
Statistical Analysis Plan  [PDF] March 29, 2017

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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT03294681    
Other Study ID Numbers: CLTD5676
First Posted: September 27, 2017    Key Record Dates
Results First Posted: June 29, 2020
Last Update Posted: June 29, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms