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Clinical Development of Deep Learning for the OtoSight

NCT04722770 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 188

Last updated 2024-01-23

No results posted yet for this study

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.

Conditions

  • Otitis Media Acute

Interventions

DEVICE

PhotoniCare OtoSight Middle Ear Scope

PhotoniCare OtoSight imaging using a near-infrared laser

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • PhotoniCare, Inc.

    lead INDUSTRY

Principal Investigators

  • Ryan Shelton, PhD · PhotoniCare, Inc.

Eligibility

Min Age
6 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-19
Primary Completion
2022-09-02
Completion
2023-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04722770 on ClinicalTrials.gov