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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01940783
Other study ID # NL44381.068.13/METC 13-1-054
Secondary ID
Status Recruiting
Phase N/A
First received September 9, 2013
Last updated September 11, 2013
Start date September 2013
Est. completion date September 2014

Study information

Verified date September 2013
Source Maastricht University Medical Center
Contact Marc van Hoof, MD
Phone +31433876543
Email marc.hoofvan@mumc.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Radiation:
Cone Beam Computed Tomography (CBCT)
Two postoperative CBCT scans, the first one on the day after cochlear implantation and the second after 3 months.
Device:
Magnetic Resonance Imaging (MRI)
One pre-operative (before cochlear implantation) MRI scan of the cochlea.

Locations

Country Name City State
Netherlands Maastricht University Medical Center Maastricht Limburg

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Advanced Bionics

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary movement of the electrode post-operatively in millimetres 3 months No
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