Clinical Development of Deep Learning for the OtoSight

PhotoniCare

Status: Completed

Conditions: Otitis Media Acute

Treatments: Device: PhotoniCare OtoSight Middle Ear Scope

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT04722770

000002

R44DC017422 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 6 months to 4 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

188 participants in 1 patient group

Pediatric patients with possible ear infections

Description:

Pediatric patients presenting with otitis media (acute otitis media or otitis media with effusion) will be imaged with the PhotoniCare OtoSight.

Treatment:

Device: PhotoniCare OtoSight Middle Ear Scope