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

NCT06285812 | Active Not Recruiting FDA Device

• 1 other identifier: 000003
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Otitis Media Acute

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change the clinician rate of antibiotic prescriptions

  Antibiotic stewardship

  Baseline to 12 month Follow Up

• Change the number of antibiotic rounds per patient

  Antibiotic stewardship

  Baseline to 12 month Follow Up

• Change costs associated with management of pediatric patients presenting with ear-related pain

  Change in overall costs

  Baseline to 21 month Follow Up

Secondary Outcomes (9)

• Change in unnecessary antibiotic prescriptions

  Baseline to 12 month Follow Up

• Change in prescription adherence

  Baseline to 12 month Follow Up

• Change in antibiotic prescription rate when fluid not present

  Baseline to 12 month Follow Up

• Improve patient outcomes

  Baseline to 12 month Follow Up

• Change medical resource utilization

  Baseline to 30 days Follow Up

Study Arms (4)

Standard of Care #1

Prospective Randomized Control Trial (RCT)

OtoSight #1

Prospective Randomized Control Trial (RCT)

Device: OtoSight Middle Ear Scope

OtoSight #2

Case and provider match

Device: OtoSight Middle Ear Scope

Standard of Care #2

Retrospective case and provider matched controls

Interventions

OtoSight Middle Ear Scope DEVICE

Subjects will be evaluated with the OtoSight Middle Ear Scope

OtoSight #1; OtoSight #2

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• PhotoniCare, Inc.: lead
• TTi Health Research & Economics: collaborator

Study Sites (7)

Children's National Hospital

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

Location

Abba Medical Group LLC

Miami, Florida, 33175, United States

Location

AdventHealth Children's Research

Orlando, Florida, 32802, United States

Location

Trillim Health

Rochester, New York, 14620, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Carolina ENT

Orangeburg, South Carolina, 29118, United States

Location

HealthStar Physicians

Morristown, Tennessee, 37813, United States

Location

MeSH Terms

Conditions

Otitis Media; Otitis Media with Effusion; Otitis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 29, 2024
• Study Start: January 10, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 30, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)