Cochlear ImplantationABMS1NCT01940783
Assessment of the AB HiFocusTM Mid Scala Electrode Movement Using Cone Beam Imaging Following Cochlea Implantation
A study testing Cone Beam Computed Tomography (CBCT) and Magnetic Resonance Imaging (MRI) in people with Cochlear Implantation and Cone-Beam Computed Tomography, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
One of the contributing factors to the variability in outcomes amongst Cochlear Implant (CI) recipients was reported to be the placement of the electrode array in the scala tympani. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implantation, Cone-Beam Computed Tomography
- What is being tested?
- Cone Beam Computed Tomography (CBCT) and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to Sep 2014
- Phase
- Interventional
- 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
Who may be able to join
- Adults 18y or older meeting the conventional Dutch CI criteria
- The patient will receives the HiFocus Mid Scala electrode
- No cochlear or neural abnormalities that could compromise the placement of the electrode as assessed by the CI surgeon
Who cannot join
- Physical or non-physical contraindications for MRI or CT imaging
- No additional disabilities that may prevent active participation and testing as per protocol
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6202 AZ
Marc van Hoof, MD, +31433876543, marc.hoofvan@mumc.nl
Guido Dees, MD MSc, +31433876543, guido.dees@mumc.nl
About this study
One of the contributing factors to the variability in outcomes amongst Cochlear Implant (CI) recipients was reported to be the placement of the electrode array in the scala tympani. It seems that the correct placement of the electrode initially into the scala tympani and subsequent avoidance of dislocation into the scala vestibuli as the insertion progresses, is a key factor in achieving good speech perception outcomes. Another important aspect related to the performance is the achievement of consistent electrical coverage with the electrode. Data reported for electrodes of different manufacturers give depths ranging from 240 - 600 degrees showing the considerable variation across subjects. The HiFocus mid scala electrode was developed to cover one and a quarter turn and with the pre-curved design to be less susceptible to variations in individual cochlea dimensions and insertion techniques. A further mechanical feature of the pre-curved design is the avoidance of forces against the cochlear lateral wall and associated lower susceptibility of the electrode for moving out of the cochlea following insertion. Recently, a cone beam CT (CBCT) technique is being explored in the field of ENT with the potential to overcome some of the issues associated with the conventional CT techniques such as scattering, radiation and low isometric resolution. Images with comparable details to those of e.g. micro CTs are possible with much lower radiation dose. Modern imaging software i.e. 3D Slicer (www.slicer.org) may be used for 3D reconstruction, post processing and Brainsfit for registration. Registration is the alignment of two scans in the same coordinate system. This enables the identification of differences between two images recorded at time x and y. Once accurately superimposed any difference between the two images may be identified with an accuracy of 0.2 mm. Using these methods, one can assess the stability and the position of the electrode in the cochlea.
Objective: The primary objectives of this study are to evaluate the feasibility of using cone beam CT technique in combination with (high resolution) MRI to identify electrode movements following cochlear implant surgery and identify the inter-scalar position of the HFms electrode. The secondary objective is to quantify the average insertion depth and variations of the HFms electrode
- Being tested
- Cone Beam Computed Tomography (CBCT), Magnetic Resonance Imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam Computed Tomography (CBCT)Radiation
Two postoperative CBCT scans, the first one on the day after cochlear implantation and the second after 3 months.
Magnetic Resonance Imaging (MRI)Device
One pre-operative (before cochlear implantation) MRI scan of the cochlea.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | All participants in the study will receive one pre-operative MRI, prior to cochlear implantation, and two cone-beam computed tomography scans, after cochlear implantation Receives: Radiation: Cone Beam Computed Tomography (CBCT); Device: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
movement of the electrode post-operatively in millimetres
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantationStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Bionics
- Responsible party
- Principal investigator, Guido Dees, Maastricht University Medical Center
- Investigators
- Robert Stokroos, MD PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940783
- Sponsor's protocol ID
- NL44381.068.13/METC 13-1-054
- Acronym
- ABMS1
- Status last verified
- Sep 2013
- First submitted
- 9 Sep 2013
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the AB HiFocusTM Mid Scala Electrode Movement Using Cone Beam Imaging Following Cochlea Implantation
- ClinicalTrials.gov ID
- NCT01940783
- Acronym / sponsor ID
- ABMS1 / NL44381.068.13/METC 13-1-054
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Advanced Bionics
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 12 Sep 2013 (estimated)
- 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.
One of the contributing factors to the variability in outcomes amongst Cochlear Implant (CI) recipients was reported to be the placement of the electrode array in the scala tympani. It seems that the correct placement of the electrode initially into the scala tympani and subsequent avoidance of dislocation into the scala vestibuli as the insertion progresses, is a key factor in achieving good speech perception outcomes. Another important aspect related to the performance is the achievement of consistent electrical coverage with the electrode. Data reported for electrodes of different manufacturers give depths ranging from 240 - 600 degrees showing the considerable variation across subjects. The HiFocus mid scala electrode was developed to cover one and a quarter turn and with the pre-curved design to be less susceptible to variations in individual cochlea dimensions and insertion techniques. A further mechanical feature of the pre-curved design is the avoidance of forces against the cochlear lateral wall and associated lower susceptibility of the electrode for moving out of the cochlea following insertion. Recently, a cone beam CT (CBCT) technique is being explored in the field of ENT with the potential to overcome some of the issues associated with the conventional CT techniques such as scattering, radiation and low isometric resolution. Images with comparable details to those of e.g. micro CTs are possible with much lower radiation dose. Modern imaging software i.e. 3D Slicer (www.slicer.org) may be used for 3D reconstruction, post processing and Brainsfit for registration. Registration is the alignment of two scans in the same coordinate system. This enables the identification of differences between two images recorded at time x and y. Once accurately superimposed any difference between the two images may be identified with an accuracy of 0.2 mm. Using these methods, one can assess the stability and the position of the electrode in the cochlea.
Objective: The primary objectives of this study are to evaluate the feasibility of using cone beam CT technique in combination with (high resolution) MRI to identify electrode movements following cochlear implant surgery and identify the inter-scalar position of the HFms electrode. The secondary objective is to quantify the average insertion depth and variations of the HFms electrode
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Radiation: Cone Beam Computed Tomography (CBCT), Device: Magnetic Resonance Imaging (MRI)All participants in the study will receive one pre-operative MRI, prior to cochlear implantation, and two cone-beam computed tomography scans, after cochlear implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18y or older meeting the conventional Dutch CI criteria
- The patient will receives the HiFocus Mid Scala electrode
- No cochlear or neural abnormalities that could compromise the placement of the electrode as assessed by the CI surgeon
Key exclusion criteria (2 listed)
- Physical or non-physical contraindications for MRI or CT imaging
- No additional disabilities that may prevent active participation and testing as per protocol
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 |
|---|---|---|
| Cone Beam Computed Tomography (CBCT)Two postoperative CBCT scans, the first one on the day after cochlear implantation and the second after 3 months. | Radiation | Intervention |
| Magnetic Resonance Imaging (MRI)One pre-operative (before cochlear implantation) MRI scan of the cochlea. | Device | Intervention |
Primary outcome
movement of the electrode post-operatively in millimetres
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.
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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.
Robert Stokroos, MD PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone Beam Computed Tomography (CBCT) and Magnetic Resonance Imaging (MRI) in people with Cochlear Implantation and Cone-Beam Computed Tomography, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 2 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 12 Sep 2013. 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 Netherlands. 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 Marc van Hoof, MD (+31433876543, marc.hoofvan@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
movement of the electrode post-operatively in millimetres (time frame: 3 months). 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 12 Sep 2013.