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Prosthesis

3D CAD/CAM autograft prosthesis for Otitis Media

N/A
Waitlist Available
Led By Glenn Knox, M.D., J.D.
Research Sponsored by Nitinetics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative; 6weeks, 3 months, and 6 months postoperatively.
Awards & highlights

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are 18 years or older and have a middle ear disease that requires surgery to fix the bones in your ear.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative; 6weeks, 3 months, and 6 months postoperatively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative; 6weeks, 3 months, and 6 months postoperatively. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cost savings
Secondary outcome measures
ABG
Number of participants that experience device rejection
Number of participants with treatment related adverse events as assessed by CTCAE v4.0

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational deviceExperimental Treatment1 Intervention
Subject receives the 3D CAD/CAM autograft prosthesis implant.
Group II: ControlActive Control1 Intervention
Subjects receive the control device.

Find a Location

Who is running the clinical trial?

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI
~1 spots leftby Apr 2025