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OtoSight #1 for Ear Infection (OTO-MATIC Trial)

N/A
Recruiting
Research Sponsored by PhotoniCare, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 21 month follow up
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Ear Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 21 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 21 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change costs associated with management of pediatric patients presenting with ear-related pain
Change the clinician rate of antibiotic prescriptions
Change the number of antibiotic rounds per patient
Secondary study objectives
Change in Health-related Quality of Life (HQoL)
Change in antibiotic prescription rate when fluid not present
Change in prescription adherence
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Standard of Care #2Experimental Treatment0 Interventions
Retrospective case and provider matched controls
Group II: Standard of Care #1Experimental Treatment0 Interventions
Prospective Randomized Control Trial (RCT)
Group III: OtoSight #2Experimental Treatment1 Intervention
Case and provider match
Group IV: OtoSight #1Experimental Treatment1 Intervention
Prospective Randomized Control Trial (RCT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OtoSight Middle Ear Scope
2019
N/A
~110

Find a Location

Who is running the clinical trial?

PhotoniCare, Inc.Lead Sponsor
2 Previous Clinical Trials
298 Total Patients Enrolled
TTi Health Research & EconomicsUNKNOWN
~396 spots leftby Dec 2025
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