An observational study in Otitis Media Acute, sponsored by PhotoniCare, Inc.. Active, not recruiting at 7 sites in United States. Open to participants aged 6 Months to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by PhotoniCare, Inc. · Observational
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.
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).
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's planned enrollment of 700 is above the median of 150 across 57 observational studies indexed under Otitis Media.
Browse Otitis Media studies →PhotoniCare, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
For the Prospective Subjects
Inclusion Criteria:
Exclusion Criteria:
For the Retrospective Case Match Controls
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prospective Randomized Control Trial (RCT)
Prospective Randomized Control Trial (RCT)
Device: OtoSight Middle Ear Scope
Case and provider match
Device: OtoSight Middle Ear Scope
Retrospective case and provider matched controls
Subjects will be evaluated with the OtoSight Middle Ear Scope
Change the clinician rate of antibiotic prescriptions
Antibiotic stewardship
Time frame: Baseline to 12 month Follow Up
Change the number of antibiotic rounds per patient
Antibiotic stewardship
Time frame: Baseline to 12 month Follow Up
Change costs associated with management of pediatric patients presenting with ear-related pain
Change in overall costs
Time frame: Baseline to 21 month Follow Up
Change in unnecessary antibiotic prescriptions
Change in unnecessary antibiotic prescriptions based on reported diagnosis and treatment recommendations of providers
Time frame: Baseline to 12 month Follow Up
Change in prescription adherence
Change in prescription adherence
Time frame: Baseline to 12 month Follow Up
Change in antibiotic prescription rate when fluid not present
Change in antibiotic prescriptions rate when fluid is not present based on reported treatment recommendations of providers
Time frame: Baseline to 12 month Follow Up
Improve patient outcomes
Change in progression to recurrent AOM (rAOM) based on tracking provider diagnoses
Time frame: Baseline to 12 month Follow Up
Change medical resource utilization
Change in follow-up visit frequency, ENT (Ear, Nose, and Throat) referral frequency
Time frame: Baseline to 30 days Follow Up
Change unnecessary medical intervention
Change in amount of unnecessary medical intervention (e.g., tympanostomy tube surgeries) based on tracking provider treatment recommendations and diagnoses
Time frame: Baseline to 12 month Follow Up
Impact clinician confidence
Change in clinician confidence scores reported on Provider CRF
Time frame: Baseline to 12 month Follow Up
Impact caregiver satisfaction
Change in clinician satisfaction scores reported on Provider CRF
Time frame: Baseline to 12 month Follow Up
Change in Health-related Quality of Life (HQoL)
Change in HQoL scores reported on the OMO-22 and OM-6
Time frame: Baseline to 12 month Follow Up
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Jun 2026, 29 months after the start.
Of 22 observational studies under Otitis Media, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 67. This study's planned 29 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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PhotoniCare, Inc.