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OtoSight #1 for Acute Otitis Media (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

OTO-MATIC Trial 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
  • Acute Otitis Media

OTO-MATIC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in Health-related Quality of Life (HQoL)
Change in antibiotic prescription rate when fluid not present
Change in prescription adherence
+6 more

OTO-MATIC 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
2023. "Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06285812.
All > Paid Studies Baltimore > Vancouver
~44 spots leftby May 2024
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