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Assessment of the AB HiFocusTM Mid Scala Electrode Movement Using Cone Beam Imaging Following Cochlea Implantation

Assessment of the AB HiFocusTM Mid Scala Electrode Movement Using Cone Beam Imaging Following Cochlea Implantation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01940783
Acronym
ABMS1
Enrollment
14
Registered
2013-09-12
Start date
2013-09-30
Completion date
2014-09-30
Last updated
2013-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Implantation, Cone-Beam Computed Tomography

Brief 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. 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

Interventions

Two postoperative CBCT scans, the first one on the day after cochlear implantation and the second after 3 months.

DEVICEMagnetic Resonance Imaging (MRI)

One pre-operative (before cochlear implantation) MRI scan of the cochlea.

Sponsors

Advanced Bionics
CollaboratorINDUSTRY
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Physical or non-physical contraindications for MRI or CT imaging * No additional disabilities that may prevent active participation and testing as per protocol

Design outcomes

Primary

MeasureTime frame
movement of the electrode post-operatively in millimetres3 months

Countries

Netherlands

Contacts

Primary ContactMarc van Hoof, MD
marc.hoofvan@mumc.nl+31433876543
Backup ContactGuido Dees, MD, MSc
guido.dees@mumc.nl+31433876543

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026