Hearing LossNCT03294681
Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms
An observational study of Hearing Loss, run by Cochlear at 6 sites in 3 countries.
Trial summary
The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Objective measures with CSEP
- Type of treatment
- Medical device
- How many people
- 153 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 3 Oct 2017to 29 May 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Routine patients undergoing a standard cochlear implantation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany3 sites
Hals-Nasen-Ohren-Klinik Universitätsklinikum Erlangen
Erlangen
Klinik für Hals-, Nasen-, Ohrenheilkunde Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt am Main
Universitätsklinikum Schleswig- Holstein - Campus Kiel Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
Kiel
Spain2 sites
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria
Clinica Universitaria de Navarra
Pamplona
About this study
Official title: 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.
- Conditions
- Hearing Loss
- Being tested
- Objective measures with CSEP
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Objective measures with CSEPDevice
Objective measures to be conducted with Custom SoundTM EP 5 software and the CP900 series sound processor in CI532 and CI512 Cochlear Implant recipients
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant Recipients | Not described Receives: Device: Objective measures with CSEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at surgery, within one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start3 Oct 2017
- Primary completion29 May 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bart Volckaerts, PhD, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294681
- Sponsor's protocol ID
- CLTD5676
- Status last verified
- Jun 2020
- First submitted
- 15 Sep 2017
- Last updated
- 29 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35306487
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-impedance Matrix
- ClinicalTrials.gov ID
- NCT03294681
- Acronym / sponsor ID
- CLTD5676
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Posted 29 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant Recipients | – | Device: Objective measures with CSEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Routine patients undergoing a standard cochlear implantation.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Objective measures with CSEPObjective measures to be conducted with Custom SoundTM EP 5 software and the CP900 series sound processor in CI532 and CI512 Cochlear Implant recipients | Device | Cochlear Implant Recipients |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35306487Hoppe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Volckaerts, PhD study director
Cochlear
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Cochlear at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Spain, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over (time frame: at surgery, within one minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03294681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.