3D CAD/CAM autograft prosthesis for Otitis Media

Phase-Based Progress Estimates
University of Florida-Jacksonville, Jacksonville, FLOtitis Media3D CAD/CAM autograft prosthesis - Device
All Sexes
What conditions do you have?

Study Summary

This trial will study the use of 3D CAD/CAM technology in the operating room for middle ear surgery. Two types of middle ear implants will be used, and the results will be analyzed to see if the technology is effective.

Eligible Conditions
  • Otitis Media

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: preoperative; 6weeks, 3 months, and 6 months postoperatively.

6 months
Number of participants that experience device rejection
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
Cost savings
Month 6

Trial Safety

Trial Design

2 Treatment Groups

1 of 2
Investigational device
1 of 2

Active Control

Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: 3D CAD/CAM autograft prosthesis · No Placebo Group · N/A

Investigational device
Experimental Group · 1 Intervention: 3D CAD/CAM autograft prosthesis · Intervention Types: Device
ActiveComparator Group · 1 Intervention: Control device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: preoperative; 6weeks, 3 months, and 6 months postoperatively.

Who is running the clinical trial?

Nitinetics LLCLead Sponsor
Glenn Knox, M.D., J.D.Principal InvestigatorNitinetics LLC

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years or older and have a middle ear disease that requires surgery to fix the bones in your ear.

Frequently Asked Questions

How many participants are currently enrolled in this experimental research?

"Affirmative. The information provided by clinicaltrials.gov demonstrates that this medical trial is actively seeking participants, which began being recruited on March 1st 2016 and was last updated September 22nd 2020. 10 volunteers are needed to be enrolled at a single site for the experiment." - Anonymous Online Contributor

Unverified Answer

Is this research study presently enrolling participants?

"Correct. According to clinicaltrials.gov, this investigation is presently looking for volunteers; the study was first published on March 1st 2016 and most recently updated on September 22nd 2020. A total of 10 participants are required from a single medical site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.