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

Status unconfirmed · Not applicable

Conditions studied: Middle Ear Disease

In brief

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.

Key facts

Study ID

NCT03297736

Run by

Nitinetics LLC

People needed

10

Starts

2016-03-01

Expected to finish

2023-03-31

Last updated by the study team

2020-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction

You may not qualify if…

• congenital anomalies

Where it is running

• University of Florida-Jacksonville — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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