New ear scanner could slash unnecessary antibiotics in kids
NCT ID NCT06285812
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a device called OtoSight that helps doctors see inside a child's ear more clearly. The goal is to see if using it leads to fewer unnecessary antibiotic prescriptions, better outcomes, and lower costs. About 700 children aged 6 months to 17 years with ear pain are taking part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 700 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Any pediatric patient between 6 months and 17 years of age scheduled for an office visit with ear-related complaints, deemed suitable for otoscopy assessment.
- Ages
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6 months to 17 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
For the Prospective Subjects Inclusion Criteria: * Pediatric subjects between 6 months and 17 years of age * Pediatric subjects presenting for an office visit with ear-related pain (otalgia)/otic complaints/earache indicative of potential Otitis Media with Effusion (OME) or Acute Otitis Media (AOM) * Pediatric subjects where otoscopy would traditionally be indicated * Pediatric subjects whose parents or legally authorized representative (LAR) have signed an informed consent Exclusion Criteria: * The parent or guardian who attends visits does not speak the same language as their physician * Pediatric subjects enrolled in another clinical trial * Pediatric subjects with: * Signs of severe chronic illness (e.g., immunodeficiency, congenital heart disease, encephalopathy, pulmonary disease other than asthma, and disorder of the ear, nose and throat) or any clinically significant illness or condition that, in the opinion of the investigator, would prohibit the subject from participating in the trial * Anatomical conditions that would affect their ability to undergo an otoscopy. For the Retrospective Case Match Controls Inclusion Criteria: * Pediatric subjects between 6 months and 17 years of age (\< 18 years old). * Index visit took place 11 - 25 months prior to the Treatment match's Baseline Visit. * Index visit was for an ear-related chief complaint. * An otoscopic exam was completed at index visit. * Subjects have a follow up visits (telehealth included) in the time period between the index visit and firstTreatment subject's enrollment date.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Abba Medical Group LLC
Miami, Florida, 33175, United States
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AdventHealth Children's Research
Orlando, Florida, 32802, United States
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Carolina ENT
Orangeburg, South Carolina, 29118, United States
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Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
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Cyn3rgy Research
Gresham, Oregon, 97030, United States
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HealthStar Physicians
Morristown, Tennessee, 37813, United States
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Trillim Health
Rochester, New York, 14620, United States
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