NCT07500532 · Medentum Innovations
Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma
What this 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.
View original scientific description
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.
Interventions
DEVICE
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 AOM and strep pharyngitis
DEVICE
Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation
Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation
OTHER
Routine Asthma Management (in-person and telehealth visits)- Control Group
* Patients randomized to the control group will receive standard care through routine in-office visits or telehealth visits. * Patients in the control group will visit the clinic whenever they experience symptoms related to their asthma condition or any other non-respiratory, non-ENT medical condition. * Telehealth visits will be offered as per routine and determined by the medical provider. * Asthma patients will undergo a physical exam, and other lab studies (e.g. Covid, strep tests) as determined by the provider to aid in diagnosis and treatment plan. The medical provider will make a diagnosis based on these routine in-office or telehealth assessments. * Control group patients will have routine well-care in-office follow-ups at a frequency as determined by their routine provider.
OTHER
Routine ENT Management (in-person and telehealth visits)- Control Group
* Patients randomized to the control group will receive standard care through routine in-office visits or telehealth visits. * Patients in the control group will visit the clinic whenever they experience symptoms related to their ENT condition or any other non-respiratory, non-ENT medical condition. * Telehealth visits will be offered as per routine and determined by the medical provider. * ENT patients will undergo a physical exam, and other lab studies (e.g. Covid, strep tests) as determined by the provider to aid in diagnosis and treatment plan. The medical provider will make a diagnosis based on these routine in-office or telehealth assessments. * Control group patients will have routine well-care in-office follow-ups at a frequency as determined by their routine provider.
Primary outcome measures
Diagnostic concordance between AI and physician/clinician
Time frame: 6 months
Arms and Interventions: Participants will be randomized to (1) home-based use of the Diagnostik device with telehealth-supported clinician evaluation or (2) in-clinic standard-of-care evaluation. Primary Outcome: Agreement between AI-generated diagnosis and clinician diagnosis obtained during the study encounter. Clinician diagnosis will be determined via telehealth evaluation in the Diagnostik arm and in-person standard-of-care evaluation in the control arm. Participants will use the Diagnostik device to collect lung auscultation recordings via digital stethoscope and capture ear or throat images. AI algorithms will assess lung sounds for presence or absence of wheeze and images for acute otitis media and pharyngitis. Clinicians will establish diagnoses based on their respective evaluation modality. Agreement between AI and clinician diagnoses will be assessed separately for asthma and ENT conditions using percent agreement and Cohen's kappa. A concordance rate ≥85% is anticipated.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Tuscon, Arizona
Collaborators
University of Arizona, National Institutes of Health (NIH), El Rio Community Health Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations