Status:
UNKNOWN
Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
Lead Sponsor:
Nitinetics LLC
Conditions:
Middle Ear Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment. Study participants, requiring middle ear surgery and ossicular reconstruction, will be implanted with one of ...
Detailed Description
Conventional middle ear prosthetic prosthetics, including total ossicular replacement prostheses (TORPs) and partial ossicular replacement prostheses (PORPs) are expensive, require large inventories f...
Eligibility Criteria
Inclusion
- at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction
Exclusion
- congenital anomalies
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03297736
Start Date
March 1 2016
End Date
March 31 2023
Last Update
September 24 2020
Active Locations (1)
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1
University of Florida-Jacksonville
Jacksonville, Florida, United States, 32209