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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00587262
Other study ID # 06-004832
Secondary ID
Status Completed
Phase N/A
First received December 21, 2007
Last updated December 30, 2015
Start date October 2006
Est. completion date September 2009

Study information

Verified date September 2009
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 100 Years
Eligibility 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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The aim of our study is to determine surgical placement of the short electrode of cochlear implants in patients with high frequency loss. Two years No
Secondary 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. Two Years No
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