- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03890107
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
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
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Washington, District of Columbia, United States, 20010
- Children's National Health System
-
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Illinois
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Urbana, Illinois, United States, 61801
- Carle Foundation Hospital
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-
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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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