Nucleus Freedom Cochlear Implant System Pediatric Post-Approval Study

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2007 by Cochlear.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Cochlear

ClinicalTrials.gov Identifier:

NCT00589511

First received: December 23, 2007

Last updated: January 8, 2008

Last verified: December 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	December 23, 2007
Last Updated Date	January 8, 2008
Start Date ^ICMJE	October 2006
Estimated Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 8, 2008)	IT-MAIS [ Time Frame: 12 Months ] [ Designated as safety issue: No ] MAIS [ Time Frame: 12 Months ] [ Designated as safety issue: No ] MLNT [ Time Frame: 12 Months ] [ Designated as safety issue: No ] LNT [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00589511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
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	Nucleus Freedom Cochlear Implant System Pediatric Post-Approval Study
Official Title ^ICMJE	Not Provided
Brief Summary	The objective of this multisite study is to evaluate the performance of the Nucleus Freedom cochlear implant system in a large population of sequentially implanted pediatric subjects.
Detailed Description	The proposed study will include 50 pediatric subjects ages 1 year to 17 years, 11 months of age, implanted at up to 5 sites in the United States and Canada. The estimated duration of this multisite study is 18 to 24 months. The duration of individual subject participation is not to exceed 12 months. The study will be conducted as a within-subject repeated measures experiment (in which each subject serves as his or her own control) in order to accommodate the heterogeneity that is well known to characterize hearing-impaired populations
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Children with bilateral severe to profound sensorineural hearing loss who undergo implantation with the Nucleus Freedom Cochlear Implant System
Condition ^ICMJE	Sensorineural Hearing Loss
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	February 2008
Estimated Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 1 year to 17 years, 11 months of age. Bilateral severe to profound sensorineural hearing loss for those 1 to 2 years of age. Severe hearing loss for those 2 years of age and older. Limited benefit from bilateral hearing aids. Limited benefit is defined as a lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and intensive aural rehabilitation over a 3 to 6 month period. For younger children, unable to take speech perception tests due to age-related cognitive and linguistic limitations, limited benefit will be quantified using the Infant Toddler Meaningful Auditory Integration Scale (IT-MAIS)1 or Meaningful Auditory Integration Scale (MAIS)1. For older children, capable of speech perception tasks, limited benefit is defined as £ 30% on the recorded open-set Multisyllabic Lexical Neighborhood Test (MLNT)2 or Lexical Neighborhood Test (LNT) 2, depending on the child's cognitive and linguistic skills. English spoken as a primary language. Willingness to participate in and to comply with all requirements of the protocol. Exclusion Criteria: Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array, as confirmed by medical examination and tests including MRI. Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and tests including MRI. Medical or psychological conditions that would contraindicate undergoing surgery (e.g., active middle ear infections, tympanic membrane perforation). Additional handicaps that would prevent or restrict participation in the evaluations. Unrealistic expectations on the part of the subject or subject's parents/guardians, regarding the possible benefits, risks and limitations that are inherent to the surgical procedure and prosthetic device. Unwillingness or inability of the candidate or candidate's parents/guardians to comply with all study requirements.
Gender	Both
Ages	1 Year to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00589511
Other Study ID Numbers ^ICMJE	CORP5183
Has Data Monitoring Committee	Not Provided
Responsible Party	Regulatory Manager, cochlear Americas
Study Sponsor ^ICMJE	Cochlear
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Cochlear
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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