ACTIVE_NOT_RECRUITING

Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children

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Conditions

Otitis Media AcuteOtitis Media with EffusionEar InfectionOptical Coherence TomographyOtitis MediaMachine Learning

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs.

Official Title

OTO-MATIC: Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children

Quick Facts

Study Start:2024-01-10
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06285812

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.

Ages Eligible for Study:6 Months to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Pediatric subjects between 6 months and 17 years of age
  2. * 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)
  3. * Pediatric subjects where otoscopy would traditionally be indicated
  4. * Pediatric subjects whose parents or legally authorized representative (LAR) have signed an informed consent
  1. * The parent or guardian who attends visits does not speak the same language as their physician
  2. * Pediatric subjects enrolled in another clinical trial
  3. * Pediatric subjects with:
  4. * 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
  5. * Anatomical conditions that would affect their ability to undergo an otoscopy.

Contacts and Locations

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States
Abba Medical Group LLC
Miami, Florida, 33175
United States
AdventHealth Children's Research
Orlando, Florida, 32802
United States
Trillim Health
Rochester, New York, 14620
United States
Cyn3rgy Research
Gresham, Oregon, 97030
United States
Carolina ENT
Orangeburg, South Carolina, 29118
United States
HealthStar Physicians
Morristown, Tennessee, 37813
United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2024-01-10
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2024-01-10
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Otitis Media with Effusion
  • Ear Infection
  • Optical Coherence Tomography
  • Otitis Media
  • Machine Learning

Additional Relevant MeSH Terms

  • Otitis Media Acute