Clinical Evaluation of the OtoSight

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.

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Health System, Washington D.C., District of Columbia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OtoSight Middle Ear Scope

Device

OtoSight imaging using a near-infrared laser

Primary outcomes

OtoSight imaging exam

Time frame: 1-5 minutes

Optical coherence tomography imaging to evaluate the middle ear.

Secondary outcomes

Adverse events

Time frame: Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer)

Rate of adverse events

Sponsors and collaborators

Lead sponsor

PhotoniCare, Inc.

Industry

Collaborators

Carle Foundation Hospital
Children's National Research Institute
National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2022
First posted: Mar 26, 2019
Registry last updated: May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed