Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System
NCT ID: NCT02092610
Last Updated: 2016-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2014-05-31
2015-03-31
Brief Summary
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Detailed Description
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After initiation of the 3-year CAG5173 investigation, Cochlear Bone Anchored Solutions AB launched the Cochlear Baha BIA300 Implant and Abutment, which in all critical aspects are identical to the novel implant used in the investigation.
The 36-month visit was the last visit of the investigation. Hence, no further visits were planned or scheduled for the subjects participating in that investigation.participating subjects. It is of clinical and scientific interest to evaluate the clinical performance and safety data of the implants in these subjects after an additional two-year period, in order to gain additional understanding of how implant stability and soft tissue status evolves over time with the two implant and abutment designs, and in order to evaluate long-term implant survival. No randomised controlled investigation of Baha implants with a 5-year follow-up has been conducted to date.
The rationale behind this clinical investigation is to collect long term stability, survival and tolerability data of a novel Baha implant system 5 years after implantation in a population that previously have been followed in a completed controlled investigation during a 3 year period. The collected data will enable comparison with the data gathered in the previous completed CAG5173 clinical investigation.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Implant BI300
The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long
Standard Implant BI300
The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long
Novel Implant BI300
The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.
Novel Implant BI300
The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.
Interventions
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Novel Implant BI300
The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.
Standard Implant BI300
The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
* Any factor, at the discretion of the investigator, that is considered to contraindicate participation
ALL
No
Sponsors
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Cochlear Bone Anchored Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Johan Blechert, M.Sc
Role: STUDY_DIRECTOR
Cochlear Bone Anchored Solutions AB
Locations
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Radboud University Medical Center
Nijmegen, , Netherlands
Sahlgrenska University Hospital
Gothenburg, , Sweden
Manchester Royal Infirmary
Manchester, , United Kingdom
Salford Royal hospital
Salford, Manchester, , United Kingdom
Countries
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Other Identifiers
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CBAS5562
Identifier Type: -
Identifier Source: org_study_id
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