Clinical Evaluation of the OtoSight

May 18, 2023 updated by: PhotoniCare, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Health System
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children diagnosed with otitis media and scheduled for tympanostomy tube surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric tympanostomy tube patients
Patients diagnosed with otitis media and scheduled for tympanostomy tube placement will be imaged with the OtoSight
OtoSight imaging using a near-infrared laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OtoSight imaging exam
Time Frame: 1-5 minutes
Optical coherence tomography imaging to evaluate the middle ear.
1-5 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ryan Shelton, PhD, PhotoniCare, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 22, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 000001 (Kaiser Permanente Southern California IRB)
  • R44DC014599 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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