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Scalar Localization Cochlear Electrode Array Using 64 Slice CT
This study has been completed.
Study NCT00587262   Information provided by Mayo Clinic
First Received: December 21, 2007   Last Updated: September 23, 2009   History of Changes

December 21, 2007
September 23, 2009
October 2006
September 2009   (final data collection date for primary outcome measure)
The aim of our study is to determine surgical placement of the short electrode of cochlear implants in patients with high frequency loss. [ Time Frame: Two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00587262 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Two Years ] [ Designated as safety issue: No ]
Same as current
 
Scalar Localization Cochlear Electrode Array Using 64 Slice CT
Scalar Localization of Cochlear Implant Electrode Array in Hearing Preservation Patients Using 64 Slice CT

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.

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.

 
Observational
Cohort, Prospective
Hearing Loss
 
  • Two pediatric participants with high frequency hearing loss post cochlear implant with either long or short electrode array.
  • Eight participants with high frequency hearing loss post cochlear implant with either short or long electrode array.
  • Fifteen participants from the existing Cochlear Implant data base.
Lane JI, Witte RJ, Driscoll CL, Shallop JK, Beatty CW, Primak AN. Scalar localization of the electrode array after cochlear implantation: clinical experience using 6-slice multidetector computed tomography. Otol Neurotol. 2007 Aug;28(5):658-62.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
5
September 2009
September 2009   (final data collection date for primary outcome measure)

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).
Both
8 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587262
John I. (Jack) Lane, M.D., Mayo Clinic
06-004832
Mayo Clinic
 
Principal Investigator: John (Jack) I. Lane, M.D. Mayo Clinic
Mayo Clinic
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP