NCT03890107

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

March 18, 2019

Last Update Submit

May 18, 2023

Conditions

Otitis Media

Keywords

Ear InfectionEar tubesMyringotomyOtitis MediaTympanostomy

Outcome Measures

Primary Outcomes (1)

  • OtoSight imaging exam

    Optical coherence tomography imaging to evaluate the middle ear.

    1-5 minutes

Secondary Outcomes (1)

  • Adverse events

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

Study Arms (1)

Pediatric tympanostomy tube patients

Patients diagnosed with otitis media and scheduled for tympanostomy tube placement will be imaged with the OtoSight

Device: OtoSight Middle Ear Scope

Interventions

OtoSight Middle Ear ScopeDEVICE

OtoSight imaging using a near-infrared laser

Pediatric tympanostomy tube patients

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Children (17 years old or younger) scheduled for tympanostomy tube placement

You may not qualify if:

  • Otoscopy contra-indicated or not possible per attending physician's decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Middle ear effusion, if present

MeSH Terms

Conditions

Otitis MediaOtitis

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ryan Shelton, PhD

    PhotoniCare, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 26, 2019

Study Start

April 15, 2019

Primary Completion

April 30, 2021

Study Completion

April 30, 2022

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)