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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative; 6weeks, 3 months, and 6 months postoperatively.
Awards & highlights
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ preoperative; 6weeks, 3 months, and 6 months postoperatively.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative; 6weeks, 3 months, and 6 months postoperatively.
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.
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Who is running the clinical trial?
Nitinetics LLCLead Sponsor
Glenn Knox, M.D., J.D.Principal InvestigatorNitinetics LLC
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