Using OtoSight to improve treatment of ear infections in children
OTO-MATIC: Otitis Treatment with OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
This study tests if using the OtoSight Middle Ear Scope can help doctors treat ear infections in children better than standard care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 6 Months to 17 Years |
| Sex | All |
| Sponsor | PhotoniCare, Inc. Industry-sponsored |
| Locations | 7 sites (Washington, District of Columbia and 6 other locations) |
| Trial ID | NCT06285812 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of the OtoSight Middle Ear Scope in managing pediatric patients with ear pain, specifically focusing on those with Otitis Media. Clinicians at participating sites will be randomized to either use the OtoSight intervention or provide usual care, with assessments conducted at multiple time points post-intervention. The study aims to enhance patient outcomes and reduce healthcare costs by improving diagnostic accuracy and treatment decisions. A historical matched control group will also be analyzed to assess the impact of the intervention.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients aged 6 months to 17 years presenting with ear-related pain or complaints indicative of Otitis Media.
Not a fit: Patients with severe chronic illnesses or those enrolled in another clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of ear infections in children, resulting in better health outcomes and reduced healthcare costs.
How similar studies have performed: Other studies using similar diagnostic technologies have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Washington, District of Columbia and 6 other locations
- Children's National Hospital — Washington, District of Columbia, United States (Not_yet_recruiting)
- Abba Medical Group LLC — Miami, Florida, United States (Active_not_recruiting)
- AdventHealth Children's Research — Orlando, Florida, United States (Recruiting)
- Trillim Health — Rochester, New York, United States (Recruiting)
- Cyn3rgy Research — Gresham, Oregon, United States (Recruiting)
- Carolina ENT — Orangeburg, South Carolina, United States (Recruiting)
- HealthStar Physicians — Morristown, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Madeleine M. Martine, MA
- Email: mad.martine0223@gmail.com
- Phone: 6517283403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.