Clinical Development of Deep Learning for the OtoSight

NCT ID: NCT04722770

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-19

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Otitis Media Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric patients with possible ear infections

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

PhotoniCare OtoSight Middle Ear Scope

Intervention Type DEVICE

PhotoniCare OtoSight imaging using a near-infrared laser

Interventions

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PhotoniCare OtoSight Middle Ear Scope

PhotoniCare OtoSight imaging using a near-infrared laser

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

6 Months

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

PhotoniCare, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Shelton, PhD

Role: PRINCIPAL_INVESTIGATOR

PhotoniCare, Inc.

Locations

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Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R44DC017422

Identifier Type: NIH

Identifier Source: secondary_id

View Link

000002

Identifier Type: -

Identifier Source: org_study_id

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