Clinical Development of Deep Learning for the OtoSight

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT05353569` - Coherent Optical Detection of Middle Ear Disease	N/A
	Recruiting	`NCT06285812` - Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children

NCT number	NCT04722770
Study type	Observational
Source	PhotoniCare, Inc.
Contact
Status	Completed
Phase
Start date	January 19, 2021
Completion date	August 31, 2023

Clinical Development of Deep Learning for the OtoSight

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms