Scalar Localization Cochlear Electrode Array Using 64 Slice CT
Scalar Localization of Cochlear Implant Electrode Array in Hearing Preservation Patients Using 64 Slice CT
1 other identifier
observational
5
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2006
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedJanuary 1, 2016
September 1, 2009
2.9 years
December 21, 2007
December 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (3)
1
Two pediatric participants with high frequency hearing loss post cochlear implant with either long or short electrode array.
2
Eight participants with high frequency hearing loss post cochlear implant with either short or long electrode array.
3
Fifteen participants from the existing Cochlear Implant data base.
Eligibility Criteria
Either part of the existing Cochlear Implant data base, or those persons who have had a Cochlear implant with either short or long electrode array who have had a high frequency hear loss.
You may qualify if:
- Registered in the Cochlear Implant Database.
- Patient has short or long electrode cochlear implant for high frequency hearing loss.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related 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. doi: 10.1097/MAO.0b013e3180686e26.
PMID: 17558341BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John (Jack) I. Lane, M.D.
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Radiology, College of Medicine
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 7, 2008
Study Start
October 1, 2006
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
January 1, 2016
Record last verified: 2009-09