Clinical Development of Deep Learning for the OtoSight

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.

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Key information

Conditions

Otitis Media Acute Ear Diseases Otitis Otitis Media Otitis Media with Effusion Otorhinolaryngologic Diseases

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PhotoniCare OtoSight Middle Ear Scope

Device

PhotoniCare OtoSight imaging using a near-infrared laser

Primary outcomes

PhotoniCare OtoSight imaging exam

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

Optical coherence tomography imaging to evaluate the middle ear.

Secondary outcomes

Adverse events

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

Rate of adverse events

Sponsors and collaborators

Lead sponsor

PhotoniCare, Inc.

Industry

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Pittsburgh

Registry information

Official study title

Clinical Development and Evaluation of a Deep Learning Approach to Improve Diagnostic Accuracy

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Jan 25, 2021
Registry last updated: Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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