Trials / Completed
CompletedNCT04722770
Clinical Development of Deep Learning for the OtoSight
Clinical Development and Evaluation of a Deep Learning Approach to Improve Diagnostic Accuracy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 188 (actual)
- Sponsor
- PhotoniCare, Inc. · Industry
- Sex
- All
- Age
- 6 Months – 4 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PhotoniCare OtoSight Middle Ear Scope | PhotoniCare OtoSight imaging using a near-infrared laser |
Timeline
- Start date
- 2021-01-19
- Primary completion
- 2022-09-02
- Completion
- 2023-08-31
- First posted
- 2021-01-25
- Last updated
- 2024-01-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04722770. Inclusion in this directory is not an endorsement.