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

NCT07500532 | Recruiting DMC FDA Device

• 1 other identifier: Medentum
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic concordance between AI and physician/clinician

  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.

  6 months

Secondary Outcomes (7)

• Agreement between AI-generated diagnosis and research team diagnosis.

  6 months

• Usability: Net Promoter Score

  6 months

• Emergency Room Visit

  6 months

• Unscheduled medical visit for asthma or ENT condition

  6 months

• Asthma Control Test Score

  6 months

Study Arms (4)

Moderate-to-severe pediatric asthma patients with home-based use of Diagnostik platform

EXPERIMENTAL

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

Device: Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation

Moderate-to-severe pediatric asthma patients using standard-of-care asthma management

PLACEBO COMPARATOR

Control Group receiving in-office standard of care for routine well visits, and urgent care/ED visits as needed. No Diagnostik platform use.

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

Pediatric ENT patients with standard-of-care ENT management

PLACEBO COMPARATOR

Control Group receiving in-office standard of care for routine well visits, and routine care, urgent care/ED visits as needed.

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

Pediatric ENT patients with home-based use of Diagnostik platform

EXPERIMENTAL

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

Device: Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis

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

Pediatric ENT patients with home-based use of Diagnostik platform

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

Moderate-to-severe pediatric asthma patients with home-based use of Diagnostik platform

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.

Moderate-to-severe pediatric asthma patients using standard-of-care asthma management

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.

Pediatric ENT patients with standard-of-care ENT management

Eligibility Criteria

• Age: 3 Years - 17 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medentum Innovations: lead
• University of Arizona: collaborator
• National Institutes of Health (NIH): collaborator
• El Rio Community Health Center: collaborator

Study Sites (1)

El Rio Health System

Tuscon, Arizona, 85745, United States

RECRUITING

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Starla Kiser, Medical Degree

CONTACT

276-212-1863; starla@medentum.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * 42 asthma patients: 21control (standard care), 21 intervention (use Diagnostik platform at home) * 42 ENT patients: 21 control (standard care), 21 intervention (use Diagnostik platform at home)

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: March 30, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)