|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | September 23, 2009 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00587262 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Scalar Localization Cochlear Electrode Array Using 64 Slice CT | ||||
| Official Title ICMJE | Scalar Localization of Cochlear Implant Electrode Array in Hearing Preservation Patients Using 64 Slice CT | ||||
| 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. |
||||
| Detailed 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. |
||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Hearing Loss | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups |
|
||||
| Publications * | 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. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 5 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 8 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00587262 | ||||
| Responsible Party | John I. (Jack) Lane, M.D., Mayo Clinic | ||||
| Study ID Numbers ICMJE | 06-004832 | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Mayo Clinic | ||||
| Verification Date | September 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||