NCT04722770
Completed
Not Applicable
Clinical Development and Evaluation of a Deep Learning Approach to Improve Diagnostic Accuracy
ConditionsOtitis Media Acute
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Otitis Media Acute
- Sponsor
- PhotoniCare, Inc.
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- PhotoniCare OtoSight imaging exam
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the primary care office for suspected ear infections. In this observational study, results of OtoSight imaging will not affect patient standard of care.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pediatric patients presenting for an office visit with ear-related complaints
Exclusion Criteria
- •Otoscopy contra-indicated or not possible per attending clinician's decision, Down's syndrome (due to abnormalities in ear canal anatomy)
Outcomes
Primary Outcomes
PhotoniCare OtoSight imaging exam
Time Frame: 1-5 minutes; at first and only study visit
Optical coherence tomography imaging to evaluate the middle ear.
Secondary Outcomes
- Adverse events(15-30 minutes; at first and only study visit)
Study Sites (1)
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