Status:
COMPLETED
Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique
Lead Sponsor:
Cochlear Bone Anchored Solutions
Conditions:
Deafness
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain...
Detailed Description
Despite extensive soft tissue reduction, the most common complications associated with Baha implants are related to adverse skin reactions around the abutment. The reduction of the skin also adds comp...
Eligibility Criteria
Inclusion
- Eligible for the Baha system
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01796236
Start Date
February 1 2013
End Date
November 1 2017
Last Update
February 26 2019
Active Locations (7)
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1
Service ORL
Toulouse, France, 31059
2
KNO arts, Amphia Ziekenhuis
Breda, Netherlands
3
Deventer Ziekenhuis
Deventer, Netherlands
4
Dept. ENT/KNO
Eindhoven, Netherlands, 5623