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

Part of paid clinical trials in Tuscon, Arizona.

Sponsor
Medentum Innovations
Study ID
NCT07500532
Status
Recruiting
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Conditions

  • Acute Otitis Media (AOM)
  • Asthma Exacerbation
  • Pediatric Asthma
  • Strep Pharyngitis

Eligibility Criteria

Sex
ALL
Age
3 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • 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 AOM and strep pharyngitis
  • Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation — DEVICE
    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 — OTHER
    * 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.
  • Routine ENT Management (in-person and telehealth visits)- Control Group — OTHER
    * 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.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Moderate-to-severe pediatric asthma patients with home-based use of Diagnostik platform
    Intervention Group with in-office standard of care for routine well visits, urgent care/ED visits as needed plus using the Medentum Diagnostik platform (multisensor device, + app+ AI platform) for telehealth management of asthma
  • Placebo Comparator: Moderate-to-severe pediatric asthma patients using standard-of-care asthma management
    Control Group receiving in-office standard of care for routine well visits, and urgent care/ED visits as needed. No Diagnostik platform use.
  • Placebo Comparator: Pediatric ENT patients with standard-of-care ENT management
    Control Group receiving in-office standard of care for routine well visits, and routine care, urgent care/ED visits as needed.
  • Experimental: Pediatric ENT patients with home-based use of Diagnostik platform
    Intervention Group with in-office standard of care for routine well visits, urgent care/ED visits as needed plus using the Medentum Diagnostik platform for telehealth for ENT conditions

Primary Outcome Measure

Diagnostic concordance between AI and physician/clinician [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
El Rio Health SystemTusconArizona85745
Erin Dougherty, Masters Degree
[email protected]
520-670-3909

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By research site
El Rio Health System· Tuscon, AZ

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