Clinical Trial

Middle Ear Surgery Implants

Study 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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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.

Additional Information

Official Study Title

Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts

Clinical Trial ID

NCT03297736

ParticipAid ID

PdRNLd