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

NCT ID: NCT01940783

Last Updated: 2013-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-09-30

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

Conditions

Cochlear Implantation; Cone-Beam Computed Tomography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: OTHER

Cone Beam Computed Tomography (CBCT)

Intervention Type: RADIATION

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

Magnetic Resonance Imaging (MRI)

Intervention Type: DEVICE

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

Interventions

Cone Beam Computed Tomography (CBCT)

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

Intervention Type: RADIATION

Magnetic Resonance Imaging (MRI)

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Bionics

INDUSTRY

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Guido Dees

MD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Stokroos, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Marc van Hoof, MD

Role: CONTACT

Phone: +31433876543

Email: marc.hoofvan@mumc.nl

Guido Dees, MD, MSc

Role: CONTACT

Phone: +31433876543

Email: guido.dees@mumc.nl

Facility Contacts

Marc van Hoof, MD

Role: primary

Guido Dees, MD MSc

Role: backup

Other Identifiers

NL44381.068.13/METC 13-1-054

Identifier Type: -

Identifier Source: org_study_id