Recruiting

Otologic Implants

Sponsor:

Nitinetics LLC

Code:

NCT03297736

Conditions

Middle Ear Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

3D CAD/CAM autograft prosthesis

Control device

Study Details

Brief 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

Study ID

NCT03297736

Start date

Mar 1, 2016

Status verified date

Sep, 2020

Completion date

Mar 31, 2023

Anticipated

Primary completion date

Mar 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • congenital anomalies

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

active comparator: Control

Subjects receive the control device.

experimental: Investigational device

Subject receives the 3D CAD/CAM autograft prosthesis implant.

Interventions

3D CAD/CAM autograft prosthesis

Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.

Control device

Surgical ossicular reconstruction with the standard available middle ear prosthesis.

Primary outcome measure

  • Cost savings [ Time Frame: perioperative ]

Central Contacts and Locations

Central contacts

Glenn Knox, M.D., J.D.

(904) 244-3498Glenn.Knox@jax.ufl.edu

Alisa Knox

alisa102189@yahoo.com

Locations

University of Florida-Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Glenn Knox, M.D., J.D.

904-244-3498Glenn.Knox@jax.ufl.edu

More Information

Sponsor

Nitinetics LLC

Last update posted

Sep 24, 2020

Last verified

Sep, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nitinetics LLC on 2020-09-24.