Scalar Localization Cochlear Electrode Array Using 64 Slice CT

NCT ID: NCT00587262

Last Updated: 2016-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-09-30

Brief Summary

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Insertion of electrode array in scala vestibuli, rather than the preferred location within scala tympani, leads to loss of native hearing in those patients with isolated high-frequency hearing loss undergoing cochlear implantation.

Detailed Description

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We aim to determine the surgical placement in patients with high frequency who had long electrode array insertions because they did not meet audiometric criteria for short array devices.

From this basis we will be able to determine if suboptimal insertion (e.g., in the scala vestibuli) leads to loss of low-frequency hearing in these patients. We also will look at the possibilities of using this data in predicting outcomes, modifying implant design, and perfecting surgical technique.

Conditions

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Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Two pediatric participants with high frequency hearing loss post cochlear implant with either long or short electrode array.

No interventions assigned to this group

2

Eight participants with high frequency hearing loss post cochlear implant with either short or long electrode array.

No interventions assigned to this group

3

Fifteen participants from the existing Cochlear Implant data base.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Registered in the Cochlear Implant Database.
* Patient has short or long electrode cochlear implant for high frequency hearing loss.

Exclusion Criteria

* Inability to provide consent.
* Patients with underlying otospongiosis, extensive labyrinthitis ossificans or cochlear dysplasia. (These patients would have been identified with pre-operative imaging prior to cochlear implantation).
Minimum Eligible Age

8 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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John Lane

Professor of Radiology, College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John (Jack) I. Lane, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Lane JI, Witte RJ, Driscoll CL, Shallop JK, Beatty CW, Primak AN. Scalar localization of the electrode array after cochlear implantation: clinical experience using 64-slice multidetector computed tomography. Otol Neurotol. 2007 Aug;28(5):658-62. doi: 10.1097/MAO.0b013e3180686e26.

Reference Type BACKGROUND
PMID: 17558341 (View on PubMed)

Other Identifiers

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06-004832

Identifier Type: -

Identifier Source: org_study_id

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