common.study.topics.clinical

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

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted 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