NCT04722770

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

January 23, 2024

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

January 20, 2021

Last Update Submit

January 22, 2024

Conditions

Otitis Media Acute

Keywords

Ear InfectionOtitis MediaOtitis Media with EffusionMachine Learning

Outcome Measures

Primary Outcomes (1)

  • PhotoniCare OtoSight imaging exam

    Optical coherence tomography imaging to evaluate the middle ear.

    1-5 minutes; at first and only study visit

Secondary Outcomes (1)

  • Adverse events

    15-30 minutes; at first and only study visit

Study Arms (1)

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.

Device: PhotoniCare OtoSight Middle Ear Scope

Interventions

PhotoniCare OtoSight Middle Ear ScopeDEVICE

PhotoniCare OtoSight imaging using a near-infrared laser

Pediatric patients with possible ear infections

Eligibility Criteria

Age6 Months - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children presenting to the pediatric clinic with suspected ear infection

You may qualify if:

  • Pediatric patients presenting for an office visit with ear-related complaints

You may not qualify if:

  • Otoscopy contra-indicated or not possible per attending clinician's decision, Down's syndrome (due to abnormalities in ear canal anatomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Otitis MediaOtitisOtitis Media with Effusion

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ryan Shelton, PhD

    PhotoniCare, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 25, 2021

Study Start

January 19, 2021

Primary Completion

September 2, 2022

Study Completion

August 31, 2023

Last Updated

January 23, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)