NL-OMON45173
Recruiting
Phase 3
Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique - CBAS5439
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Enrollment
- 63
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Adult patient, i.e. \* 18 years of age
- •\* Eligible for the Baha system
- •\* Signed informed consent
Exclusion Criteria
- •\* Patient scheduled for simultaneously bilateral implant surgery
- •\* Uncontrolled diabetes as judged by the investigator
- •\* Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
- •\* Unable to follow the cleaning instruction
- •\* Unable to follow investigational procedures, e.g. to complete quality of life scales
- •\* Participation in another investigation with pharmaceuticals and/or device
- •\* Condition that may have an impact on the outcome of the investigation as judged by the investigator
- •\* Suitable implant position for the 4 mm implant not found during surgery due to insufficient bone quality and/or bone thickness
Outcomes
Primary Outcomes
Not specified
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