NCT07500532 Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma
| NCT ID | NCT07500532 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medentum Innovations |
| Condition | Acute Otitis Media (AOM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2025-10-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07500532 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Acute Otitis Media (AOM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07500532 currently recruiting?
Yes, NCT07500532 is actively recruiting participants. Contact the research team at starla@medentum.com for enrollment information.
Where is the NCT07500532 trial being conducted?
This trial is being conducted at Tuscon, United States.
Who is sponsoring the NCT07500532 clinical trial?
NCT07500532 is sponsored by Medentum Innovations. The trial plans to enroll 84 participants.