Middle Ear Surgery Implants
common.study.values.description
“Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts”
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 two middle ear implants. The rationale is to complete a pilot study of the technology with a small number of designs. Each implant will be commonly used, in the public domain, and recreated by the CAD/CAM software.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
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common.study.methods.is-healthy-no
Device - 3D CAD/CAM autograft prosthesis
Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.
Device - Control device
Surgical ossicular reconstruction with the standard available middle ear prosthesis.
participant.views.study.view.additional
participant.views.study.view.scientific-title
Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
common.study.values.clinical-trial-id
NCT03297736
participant.views.study.view.id
PdRNLd
