Clinical Development of Deep Learning for the OtoSight

Otitis Media Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722770
• Other study ID #: 000002
• Secondary ID: R44DC017422
• Status: Completed
• Start date: January 19, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2023
• Source: PhotoniCare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: August 31, 2023
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 4 Years

Eligibility

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)

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media Acute

Intervention

Device:
• PhotoniCare OtoSight Middle Ear Scope
PhotoniCare OtoSight imaging using a near-infrared laser

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
PhotoniCare, Inc.	National Institute on Deafness and Other Communication Disorders (NIDCD), University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PhotoniCare OtoSight imaging exam	Optical coherence tomography imaging to evaluate the middle ear.	1-5 minutes; at first and only study visit
Secondary	Adverse events	Rate of adverse events	15-30 minutes; at first and only study visit