Clinical Development of Deep Learning for the OtoSight
Completed
- Conditions
- Otitis Media Acute
- Interventions
- Device: PhotoniCare OtoSight Middle Ear Scope
- Registration Number
- NCT04722770
- Lead Sponsor
- PhotoniCare, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pediatric patients with possible ear infections PhotoniCare OtoSight Middle Ear Scope Pediatric patients presenting with otitis media (acute otitis media or otitis media with effusion) will be imaged with the PhotoniCare OtoSight.
- Primary Outcome Measures
Name Time Method PhotoniCare OtoSight imaging exam 1-5 minutes; at first and only study visit Optical coherence tomography imaging to evaluate the middle ear.
- Secondary Outcome Measures
Name Time Method Adverse events 15-30 minutes; at first and only study visit Rate of adverse events
Trial Locations
- Locations (1)
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States