NCT06285812

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: PhotoniCare, Inc. · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

Mixed method, multi-center, pragmatic, cluster-randomized effectiveness-implementation investigation focused on pediatric subjects presenting with ear complaints at the office setting. For the prospective randomized component, eligible clinicians at a given site will be randomized to one of two groups: the OtoSight intervention group or the usual care control group. There will be three (3) periods of post-intervention assessment: 10 days (optional), 6 months, and 12 months. Eligible subjects will be automatically enrolled (or invited to enroll) in the clinical trial and will receive information. Because this is a non-interference design, frontline care clinicians randomized to either arm will be asked to: (1) assess the presence or absence of fluid in the middle ear; (2) record a diagnosis; and (3) treat the patient as they would according to the information available to them. A separate retrospective historical matched control arm will also be conducted to analyze potential Hawthorne effect at a subset of collaborating practices or healthcare systems. Randomization of clinicians (and not children) will decrease contamination in the usual practice group (i.e., so clinicians are not asked to flip between intervention and usual care practices).

Conditions

• Otitis Media Acute

Interventions

Type	Name	Description
DEVICE	OtoSight Middle Ear Scope	Subjects will be evaluated with the OtoSight Middle Ear Scope

Timeline

• Start date: 2024-01-10
• Primary completion: 2025-08-31
• Completion: 2025-12-30
• First posted: 2024-02-29
• Last updated: 2025-08-01

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study