Actively Recruiting
Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma
Led by Medentum Innovations · Updated on 2026-03-30
84
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
M
Medentum Innovations
Lead Sponsor
U
University of Arizona
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study evaluates the diagnostic performance, usability, and clinical utility of the Medentum Diagnostik platform, a multisensor device with integrated software and artificial intelligence, in pediatric patients with asthma and ENT conditions. Participants will be assigned to either home-based use of the Diagnostik platform with telehealth-supported clinician evaluation or standard in-person care. The primary objective is to assess agreement between AI-generated diagnoses and clinician diagnoses obtained during study encounters, including telehealth evaluations in the Diagnostik arm and in-person evaluations in the standard-of-care arm. Secondary objectives include evaluating agreement between AI-generated diagnoses and independent research team diagnoses, as well as assessing usability, patient and caregiver satisfaction, healthcare utilization, and clinical outcomes such as asthma control and symptom resolution. This study will also evaluate differences in healthcare utilization, including in-person visits, emergency care use, and time to diagnosis and treatment, between study groups.
CONDITIONS
Official Title
Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 4 and 17 years for asthma patients and 3 to 17 years for ENT patients
- Asthma patients diagnosed with mild-to-moderate or severe persistent asthma as per GINA guidelines with a history of symptoms or exacerbations needing medical intervention in the past 12 months
- ENT patients diagnosed with common ENT conditions such as acute otitis media or strep pharyngitis in the prior year based on clinical guidelines
- Access to a smartphone, tablet, or device capable of running the Diagnostik platform app with Wifi or cellular service
- Receiving routine care from University of Arizona or associated clinics in Arizona with active health insurance
- Parental or guardian consent for participation and child assent when appropriate (all children 7 years or older)
You will not qualify if you...
- Presence of other chronic lung diseases requiring complex specialist care such as cystic fibrosis
- Diagnosed cerebral palsy, neurodevelopmental conditions, or congenital heart disease
- Complex chronic conditions or chronic ENT conditions requiring complex specialist care
- History of tympanostomy tubes or tonsillectomy/adenoidectomy or chronic suppurative or serous otitis media
- Severe asthma exacerbations requiring hospitalization or intensive treatment within the past 4 weeks
- Speech delays, hearing impairments, or cognitive impairments that may affect use of the Diagnostik platform
- Inability of patient or family to follow study instructions, comply with follow-up visits, or properly use the Diagnostik platform
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
El Rio Health System
Tuscon, Arizona, United States, 85745
Actively Recruiting
Research Team
S
Starla Kiser, Medical Degree
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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