Clinical Development of Deep Learning for the OtoSight

PhotoniCare, Inc.188 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

188

Conditions

Otitis Media Acute

Interventions

PhotoniCare OtoSight Middle Ear ScopeDEVICE

PhotoniCare OtoSight imaging using a near-infrared laser

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 4 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

PhotoniCare OtoSight imaging exam

Optical coherence tomography imaging to evaluate the middle ear.

Time frame: 1-5 minutes; at first and only study visit

Secondary Outcomes

Adverse events

Rate of adverse events

Time frame: 15-30 minutes; at first and only study visit

Data from ClinicalTrials.gov

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