Medentum Diagnostik Platform for Pediatric Asthma and ENT Issues
Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma
Recruiting
N/AInterventional Study
Acute Otitis Media (AOM)Strep PharyngitisAsthma ExacerbationPediatric Asthma
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At a Glance
Age
3 – 17
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
84 (estimated)
Sponsor
Medentum Innovations · Industry
Who this trial is looking for
This trial is looking for kids aged 3 to 17 with asthma or common ear, nose, and throat (ENT) conditions. Participants will use a device at home that helps doctors check their health and compare it to regular office visits.
Are You a Good Fit for This Trial?
Rules you outCystic fibrosisCerebral palsyNeurodevelopmental conditionsCongenital heart disease
You may be able to join if
I am between 3 and 17 years old.
I have been diagnosed with asthma or a common ENT condition.
I have access to a smartphone or tablet with internet service.
I receive care from the University of Arizona or its clinics.
I have health insurance.
I have consent from my parent or guardian.
You may not be able to join if
I have another serious lung condition that needs special care.
I have had recent ENT surgery like tonsil removal.
I was hospitalized for asthma in the last 4 weeks.
I have hearing or speech delays that may affect my ability to use the device.
I cannot follow study instructions or attend follow-up visits.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 ca…
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.
Trial Locations
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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 exacerbatio…
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.
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