Clinical Evaluation of the TOMi Scope



Status:Not yet recruiting
Conditions:Other Indications, Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any - 17
Updated:3/28/2019
Start Date:April 2019
End Date:June 2020
Contact:Ryan Nolan, M.Eng., CCRP
Email:rnolan@photoni.care
Phone:866-411-3277

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Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance

The objective of this study is to evaluate the imaging capabilities and image analysis
performance of the PhotoniCare TOMi Scope in pediatric patients undergoing tympanostomy tube
placement for otitis media. In this observational study, results of TOMi Scope imaging will
not affect patient standard of care.


Inclusion Criteria:

- Children (17 years old or younger) scheduled for tympanostomy tube placement

Exclusion Criteria:

- Otoscopy contra-indicated or not possible per attending physician's decision
We found this trial at
2
sites
Urbana, Illinois 61801
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from
Urbana, IL
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Washington, District of Columbia 20010
Principal Investigator: Nancy Bauman, MD
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from
Washington,
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