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
8 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
Researchers are evaluating the Medentum Diagnostik platform, a multisensor device combined with software and artificial intelligence, to diagnose asthma and ear, nose, and throat (ENT) conditions in children aged 3 to 17 years. This randomized trial compares home use of the Diagnostik platform with telehealth-supported clinician evaluation to standard in-person or telehealth care. The study aims to assess how well AI diagnoses agree with clinician diagnoses and to examine usability, satisfaction, healthcare use, and clinical outcomes such as asthma control and symptom resolution. Participants are randomly assigned to either use the Diagnostik platform at home during symptoms and for monitoring (asthma patients) or to receive routine clinical care without the device. The Diagnostik platform includes a smartphone app and a device with a digital stethoscope, otoscope, thermometer, and pulse oximeter. The AI analyzes collected data to provide preliminary diagnoses, which clinicians review via telehealth. Control participants receive standard care through in-person or telehealth visits without the device. During the six-month study, participants will complete symptom records, questionnaires, and vital sign measurements. Researchers will compare AI and clinician diagnoses using lung sounds and ear/throat images, evaluate healthcare visits and emergency use, and assess patient and caregiver experiences. Data will be collected through the platform, medical records, and reports, with safety and clinical outcomes monitored throughout the study.
CONDITIONS
Brief 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
- Diagnosis of mild-to-moderate or severe persistent asthma according to GINA guidelines with recent symptoms or exacerbations, or diagnosis of common ENT conditions such as acute otitis media or strep pharyngitis within the past year
- Access to a smartphone, tablet, or device capable of running the Medentum Diagnostik 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 and child assent when appropriate (for children aged 7 years and older)
You will not qualify if you...
- Presence of other chronic lung diseases like cystic fibrosis or complex specialist care needs
- Cerebral palsy, neurodevelopmental conditions, or congenital heart disease
- Complex chronic or chronic ENT conditions requiring specialist care
- History of tympanostomy tubes, 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 affecting use of the Diagnostik platform
- Inability to follow study instructions, comply with visits, or properly use the Medentum platform
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or telehealth)
Duration - 6 months
Participants randomized to the intervention group will use the Medentum Diagnostik home-based platform during symptomatic episodes and for monthly monitoring (asthma patients). Control group participants will receive standard clinical care through routine in-office or telehealth visits.
Visits as needed during symptomatic episodes plus monthly monitoring for asthma patients in the intervention group; routine clinic visits as determined by providers in the control group
Duration - Up to 6 months
Participants are monitored through platform data, medical record reviews, and patient-reported outcomes during and after the intervention period to assess diagnostic agreement and clinical outcomes.
Data collection occurs through remote monitoring and routine medical record reviews with no additional visits required
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
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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