CompletedNot Applicable

Clinical Development of Deep Learning for the OtoSight

United States188 participantsStarted 2021-01-19

Plain-language 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.

Who can participate

Age range6 Months – 4 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

PhotoniCare OtoSight imaging exam

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

Trial details

NCT IDNCT04722770

SponsorPhotoniCare, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-02

View on ClinicalTrials.gov More Otitis Media Acute trials