Bilateral Cochlear Implant Benefit in Young Children
This study is ongoing, but not recruiting participants.
Sponsor:
Advanced Bionics
Information provided by:
Advanced Bionics
ClinicalTrials.gov Identifier:
NCT00424307
First received: January 17, 2007
Last updated: June 24, 2011
Last verified: June 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 17, 2007 | ||||
| Last Updated Date | June 24, 2011 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Assessment of Speech Perception Skills [ Time Frame: Various time points ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00424307 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Health-Related Quality of Life and Assessment of Communicative Performance [ Time Frame: Various time points ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bilateral Cochlear Implant Benefit in Young Children | ||||
| Official Title ICMJE | Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants | ||||
| Brief Summary | The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Hearing Loss | ||||
| Intervention ICMJE | Device: HiResolution Bionic Ear System
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Other Name: HiResolution Bionic Ear System |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | April 2012 | ||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Months to 36 Months | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00424307 | ||||
| Other Study ID Numbers ICMJE | ACR0906 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kenneth Ripley, Advanced Bionics, LLC | ||||
| Study Sponsor ICMJE | Advanced Bionics | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Advanced Bionics | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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