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 |
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.
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
Washington, District of Columbia 20010
Principal Investigator: Nancy Bauman, MD
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