Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
NCT ID: NCT04754477
Last Updated: 2024-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-05-06
2022-03-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active Osseointegrated Steady-State Implant System (OSI)
Active Osseointegrated Steady-State Implant System (OSI)
System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound process
Interventions
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Active Osseointegrated Steady-State Implant System (OSI)
System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound process
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide written informed consent
Exclusion Criteria
* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
18 Years
ALL
No
Sponsors
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Statistiska Konsultgruppen
OTHER
Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Karin Ganlöv, MD
Role: STUDY_DIRECTOR
Cochlear
Locations
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SCIC / NextSense
Gladesville, New South Wales, Australia
HEARnet Clinical studies
Carlton, Victoria, Australia
Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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Cowan R, Lewis AT, Hallberg C, Tong MCF, Birman CS, Ng IH, Briggs R. Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):683-691. doi: 10.1007/s00405-023-08133-3. Epub 2023 Aug 8.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CBAS5793
Identifier Type: -
Identifier Source: org_study_id
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