NCT03297736

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

5.1 years

First QC Date

September 13, 2017

Last Update Submit

September 22, 2020

Conditions

Middle Ear Disease

Outcome Measures

Primary Outcomes (1)

  • Cost savings

    operative costs compared between treatment groups utilizing total operative time in minutes

    perioperative

Secondary Outcomes (3)

  • Number of participants with treatment related adverse events as assessed by CTCAE v4.0

    6 months

  • ABG

    preoperative; 6weeks, 3 months, and 6 months postoperatively.

  • Number of participants that experience device rejection

    6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Subjects receive the control device.

Device: Control device

Investigational device

EXPERIMENTAL

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

Device: 3D CAD/CAM autograft prosthesis

Interventions

3D CAD/CAM autograft prosthesisDEVICE

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

Investigational device
Control deviceDEVICE

Surgical ossicular reconstruction with the standard available middle ear prosthesis.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida-Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

Study Officials

  • Glenn Knox, M.D., J.D.

    Nitinetics LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

Alisa Knox

CONTACT

alisa102189@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 29, 2017

Study Start

March 1, 2016

Primary Completion

March 31, 2021

Study Completion

March 31, 2023

Last Updated

September 24, 2020

Record last verified: 2020-09

Locations

US(1)