NCT07500532Recruiting
Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 2 Apr 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Medentum Innovations
- Diseases
- Asthma
- NCT number
- NCT07500532
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 1 Oct 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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)
Age in the registry: 3 years to 17 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| El Rio Health System Coordinator of this site? Confirm its status | Tuscon | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.