Recruiting

AI Diagnostik PlatformEvaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma

Sponsor:

Medentum Innovations

Code:

NCT07500532

Conditions

Acute Otitis Media (AOM)

Strep Pharyngitis

Asthma Exacerbation

Pediatric Asthma

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

Interventions

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

Routine Asthma Management (in-person and telehealth visits)- Control Group

Routine ENT Management (in-person and telehealth visits)- Control Group

Study Details

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.

Conditions

Acute Otitis Media (AOM)

Strep Pharyngitis

Asthma Exacerbation

Pediatric Asthma

Study ID

NCT07500532

Start date

Oct 1, 2025

Status verified date

Mar, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

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

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.

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 measure

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

Central Contacts and Locations

Central contacts

Starla Kiser, Medical Degree

276-212-1863 starla@medentum.com

Locations

El Rio Health System

Recruiting

Tuscon, Arizona, United States, 85745

Contacts

Erin Dougherty, Masters Degree

520-670-3909 ErinD@elrio.org

More Information

Sponsor

Medentum Innovations

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Medentum Innovations on 2026-03-30.