Sensorineural Hearing LossPATHOSNCT06223724
Status Telemetry for Cochlear Implantations
An observational study of Sensorineural Hearing Loss, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Cochlear implants (CIs) are well-established neuroprosthesis used to restore hearing for patients with partial or complete deafness. However, the audiological outcomes of these implants can vary widely, and one reason for this is suboptimal electrode placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- STOP and MAESTRO
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Oct 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult subjects eligible for a MED-EL cochlear implant of the MED-EL portfolio (Flex series array) and who meet the additional inclusion/exclusion will be approached for participation in this study.
Who may be able to join
- Informed Consent signed by the subject
- Subjects scheduled for CI surgery according to clinical routine
- Subjects who will receive a cochlear implant of the MED-EL portfolio (FLEX series arrays)
- No radiological contraindications
- Stated willingness to comply with all study procedures for the duration of the study
Who cannot join
- Lack of compliance with any inclusion criteria
- Subjects incapable of giving informed consent
- Age under 18 years
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Wilhelm Wimmer, Prof. contact
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery
Bern, 3008
About this study
Official title: Prospective Study of Status Telemetry for Cochlear Implantations
Cochlear implants (CIs) are well-established neuroprosthesis used to restore hearing for patients with partial or complete deafness. However, the audiological outcomes of these implants can vary widely, and one reason for this is suboptimal electrode placement. The gold standard for measuring electrode positions is computed tomography (CT) scans, but they are expensive and expose patients to additional radiation, which is especially harmful for children.
This study investigates an alternative approach using impedance telemetry data to estimate electrode positions without exposing patients to radiation. For this purpose, an extended telemetry version of a CE-certified cochlear implant software is used. The advanced impedance telemetry software can measure impedance subcomponents with improved measurement resolution that could be used for more accurate estimation of electrode insertion depth using specially designed estimation software.
Ultimately, the investigators want to demonstrate the potential to improve audiological outcomes of cochlear implant recipients without exposing them to additional radiation.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- STOP, MAESTRO
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOPDevice
Software to measure impedance telemetry data
MAESTRODevice
Software to measure impedance telemetry data
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant electrode insertion depth estimation | Electrode insertion depth estimation using impedance telemetry data measured during cochlear implantation and at three regular follow-up visits Receives: Device: STOP; Device: MAESTRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear error of electrode insertion depth estimation
Linear error (in mm) in impedance-based estimation of cochlear implant electrode insertion depth compared to ground truth from CT scans.
Measured: At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)
Linear error of electrode insertion depth estimation
Linear error (in mm) in impedance-based estimation of cochlear implant electrode insertion depth compared to ground truth from CT scans.
Measured: At the additional post-operative CT scan (+3 months)
Secondary outcomes (4)
Intra-operative progression of impedance subcomponents
Intra-operative measurement of access resistance and polarization impedance measured by the STOP software at several positions of the electrode array in the cochlea (stepwise insertion). The results will be expressed in kOhm (kΩ).
Measured: During cochlear implantation (day 0)
Post-operative progression of electrode insertion depth estimation
Post-operative cochlear implant electrode insertion depth estimation using a phenomenological model based on access resistance and polarization impedance measured by the STOP software after full insertion of the electrode array. The results will be expressed in kOhm (kΩ).
Measured: Recordings will be made during cochlear implant surgery (day 0) and at three follow-up visits (+2weeks, +4weeks, +12weeks).
Angular error of electrode insertion depth estimation
Angular error (in degrees) in impedance-based estimation of cochlear implant electrode insertion depth using a phenomenological model compared to ground truth from CT scans.
Measured: At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)
Angular error of electrode insertion depth estimation
Angular error (in degrees) in impedance-based estimation of cochlear implant electrode insertion depth using a phenomenological model compared to ground truth from CT scans.
Measured: At the additional post-operative CT scan (+3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start25 Oct 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Caversaccio, Prof. Dr. med., Principal investigator, Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223724
- Sponsor's protocol ID
- PATHOS
- Acronym
- PATHOS
- Status last verified
- Jan 2024
- First submitted
- 29 Jun 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Status Telemetry for Cochlear Implantations
- ClinicalTrials.gov ID
- NCT06223724
- Acronym / sponsor ID
- PATHOS / PATHOS
- Conditions
- Sensorineural Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cochlear implants (CIs) are well-established neuroprosthesis used to restore hearing for patients with partial or complete deafness. However, the audiological outcomes of these implants can vary widely, and one reason for this is suboptimal electrode placement. The gold standard for measuring electrode positions is computed tomography (CT) scans, but they are expensive and expose patients to additional radiation, which is especially harmful for children.
This study investigates an alternative approach using impedance telemetry data to estimate electrode positions without exposing patients to radiation. For this purpose, an extended telemetry version of a CE-certified cochlear implant software is used. The advanced impedance telemetry software can measure impedance subcomponents with improved measurement resolution that could be used for more accurate estimation of electrode insertion depth using specially designed estimation software.
Ultimately, the investigators want to demonstrate the potential to improve audiological outcomes of cochlear implant recipients without exposing them to additional radiation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant electrode insertion depth estimation | – | Device: STOP, Device: MAESTROElectrode insertion depth estimation using impedance telemetry data measured during cochlear implantation and at three regular follow-up visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects eligible for a MED-EL cochlear implant of the MED-EL portfolio (Flex series array) and who meet the additional inclusion/exclusion will be approached for participation in this study.
Key inclusion criteria (5 listed)
- Informed Consent signed by the subject
- Subjects scheduled for CI surgery according to clinical routine
- Subjects who will receive a cochlear implant of the MED-EL portfolio (FLEX series arrays)
- No radiological contraindications
- Stated willingness to comply with all study procedures for the duration of the study
Key exclusion criteria (4 listed)
- Lack of compliance with any inclusion criteria
- Subjects incapable of giving informed consent
- Age under 18 years
- Pregnancy
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 |
|---|---|---|
| STOPSoftware to measure impedance telemetry data | Device | Cochlear implant electrode insertion depth estimation |
| MAESTROSoftware to measure impedance telemetry data | Device | Cochlear implant electrode insertion depth estimation |
Primary outcome
Linear error of electrode insertion depth estimation
Time frame: At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)
Linear error (in mm) in impedance-based estimation of cochlear implant electrode insertion depth compared to ground truth from CT scans.
Linear error of electrode insertion depth estimation
Time frame: At the additional post-operative CT scan (+3 months)
Linear error (in mm) in impedance-based estimation of cochlear implant electrode insertion depth compared to ground truth from CT scans.
4 secondary outcomes
Intra-operative progression of impedance subcomponents
Time frame: During cochlear implantation (day 0)
Post-operative progression of electrode insertion depth estimation
Time frame: Recordings will be made during cochlear implant surgery (day 0) and at three follow-up visits (+2weeks, +4weeks, +12weeks).
Angular error of electrode insertion depth estimation
Time frame: At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)
Angular error of electrode insertion depth estimation
Time frame: At the additional post-operative CT scan (+3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Wilhelm Wimmer, Prof. contact
Marco Caversaccio, Prof. Dr. med. principal investigator
Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensorineural Hearing Loss, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan Schraivogel, MSc (+41 31 632 76 15, stephan.schraivogel@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear error of electrode insertion depth estimation (time frame: At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2024.