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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 November 2016 |
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Main ID: |
NCT02934373 |
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Date of registration:
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13/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products
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Scientific title:
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Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02934373 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Belgium
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United Kingdom
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Contacts
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Name:
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Mary Beth Brinson |
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Address:
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Telephone:
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Email:
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Affiliation:
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Head of Clinical Affairs |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 12 months old or older
2. Implanted with a CI24RE (Freedom implant) or later implant in at least one implanted
ear
3. Use of the CP810, CP920 or CP910 sound processor
4. Willingness to participate in and to comply with all requirements of the protocol
Exclusion Criteria:
1. Unrealistic expectations on the part of the subject, regarding the possible benefits,
risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities or illnesses that would prevent participation in evaluations
or compromise the integrity of the investigation or quality of data collected
3. Nucleus 22 or Nucleus 24 Implant in ear to be fitted with the investigational device
Age minimum:
1 Year
Age maximum:
100 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hearing Loss
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Intervention(s)
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Device: A New Sound Processor
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Primary Outcome(s)
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Subjective rating with a new sound processor compared to ratings with each subjects own processor
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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