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

NCT03297736 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-09-24

No results posted yet for this study

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 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.

Conditions

  • Middle Ear Disease

Interventions

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.

Sponsors & Collaborators

  • Nitinetics LLC

    lead INDUSTRY

Principal Investigators

  • Glenn Knox, M.D., J.D. · Nitinetics LLC

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2021-03-31
Completion
2023-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03297736 on ClinicalTrials.gov