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Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma

Medentum Innovations · with University of Arizona, National Institutes of Health (NIH) · NCT07500532

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 3–17 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
84
US sites recruiting
1
Study start
October 1, 2025
Record last updated
March 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis; Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation; Routine Asthma Management (in-person and telehealth visits)- Control Group; Routine ENT Management (in-person and telehealth visits)- Control Group

Conditions: Acute Otitis Media (AOM); Strep Pharyngitis; Asthma Exacerbation; Pediatric Asthma

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Age: Patients between the ages of 4 and 17 years (asthma) and 3-17 years (ENT)
  • Diagnosis:

o Asthma patients: Diagnosed with mild-to-moderate and severe persistent asthma according to Global Initiative for Asthma (GINA) guidelines, with a history of symptoms or exacerbations requiring medical intervention (prior prednisone course and/or albuterol for >24 hours in context of acute wheezing episode) in the past 12 months. ENT patients: Diagnosed with common ENT conditions such as acute otitis media (AOM) or strep pharyngitis in the prior year. Diagnosis must be based on established clinical guidelines.

  • Technology access: Must have access to a smartphone, tablet, or other device capable of running the Medentum Diagnostik platform app and access to Wifi or cellular service.
  • Care access: Must be receiving routine care from University of Arizona or associated clinics in Arizona and have active health insurance
  • Consent: Must have parental or guardian consent for participation, as well as child assent when appropriate.(all children ≥7 yrs)

Exclusion Criteria

  • Other medical conditions: Patients with additional chronic lung diseases (such as cystic fibrosis) requiring complex specialist care will be excluded. cerebral palsy, neurodevelopmental conditions, congenital heart disease. Patients with complex chronic conditions or chronic ENT conditions requiring complex specialist care will be excluded.
  • Recent surgical/complex ENT medical history: Patients who have had tympanostomy tubes or tonsillectomy/adenoidectomy, patients with chronic ENT conditions including chronic suppurative or serous otitis media
  • Recent medical history: Patients who have experienced severe asthma exacerbations requiring hospitalization or intensive treatment in the past 4 weeks
  • Comorbidities: Patients with speech delays, hearing impairments, or cognitive impairments that may affect their ability to use the Diagnostik platform accurately will be excluded.
  • Non-compliance risk: Patients or families that are unable to follow study instructions, comply with follow-up visits, or properly use the Medentum platform will be excluded.

Recruiting US locations

  • El Rio Health System

    Tuscon, AZ 85745

    Site contact: Erin Dougherty, Masters Degree · 520-670-3909 · ErinD@elrio.org

Study contacts (from the official record)

  • Starla Kiser, Medical Degree · 276-212-1863 · starla@medentum.com
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Evaluation of the Medentum Diagnostik Platform for Pediatric ENT… (NCT07500532) | Bored Studies