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NCT03890107 Clinical Trial

Clinical Evaluation of the OtoSight

Otitis Media Clinical Trial

Official title:
Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03890107
Other study ID # 000001
Secondary ID R44DC014599
Status Completed
Phase
First received
Last updated
Start date April 15, 2019
Est. completion date April 30, 2022

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

Clinical Trial Summary

The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of OtoSight imaging will not affect patient standard of care.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date April 30, 2022
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: - Children (17 years old or younger) scheduled for tympanostomy tube placement Exclusion Criteria: - Otoscopy contra-indicated or not possible per attending physician's decision

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Carle Foundation Hospital Urbana Illinois
United States Children's National Health System Washington District of Columbia

Sponsors (4)
Lead Sponsor Collaborator
PhotoniCare, Inc. Carle Foundation Hospital, Children's National Health System, National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary OtoSight imaging exam Optical coherence tomography imaging to evaluate the middle ear. 1-5 minutes
Secondary Adverse events Rate of adverse events Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer)
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