Recruiting

AI Diagnostic Evaluation

Sponsor:

Magic Health Inc. (d.b.a. Nolla Health)

Code:

NCT07470463

Conditions

Differential Diagnosis

Diagnostic Accuracy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

AI Diagnostic System (AIMD.1)

Study Details

Brief summary:

This study evaluates the diagnostic performance of a multimodal artificial intelligence (AI) system (AIMD.1) using de-identified medical images and semi-synthetic patient simulations. The study combines retrospective analysis of existing publicly available image datasets with prospective data collection from licensed clinicians who complete diagnostic evaluation tasks.

In the One-Shot Vision Differential Evaluation (OSVDE) stage, clinicians review individual de-identified medical images and generate a ranked list of potential diagnoses based solely on visual features. In the Multi-Step Conversational Non-Inferiority Evaluation (MSCNE) stage, clinicians complete diagnostic assessments using semi-synthetic patient simulations derived from de-identified medical images. Clinician performance will be compared with the AI system on the same diagnostic tasks.

Human participants consist solely of licensed clinicians who provide diagnostic responses. Medical images and simulated cases are study materials and are not considered study participants. No identifiable patient data are used, and the AI system is evaluated in an offline research environment and is not used for clinical decision-making or patient care.

Conditions

Differential Diagnosis

Diagnostic Accuracy

Study ID

NCT07470463

Start date

Mar 19, 2026

Status verified date

Mar, 2026

Completion date

Sep 19, 2026

Anticipated

Primary completion date

Sep 19, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Active license in Dermatology, Internal Medicine, Otolaryngology, Gynecology, Orthopedics, Pediatrics, Geriatrics, Emergency Medicine, Ophthalmology, Psychiatry, Endocrinology, Family Medicine, or a closely related specialty
  • Age 18 years or older
  • Ability to complete diagnostic evaluation sessions remotely using a computer or tablet with reliable internet access

Exclusion Criteria:

  • Loss of active license in an eligible specialty
  • Inability to complete the evaluation session remotely

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Clinician Participants

Licensed clinicians who participate in diagnostic evaluation tasks using de-identified medical images and semi-synthetic patient simulations to assess diagnostic accuracy. Clinicians provide differential diagnoses for benchmark comparison with an AI diagnostic system.

Interventions

AI Diagnostic System (AIMD.1)

AIMD.1 (also known as NollaMD agent) is a multimodal artificial intelligence (AI) diagnostic system designed to generate differential diagnoses based on analysis of medical images and structured clinical information. In this study, the system is evaluated using de-identified medical images and semi-synthetic patient simulations under controlled research conditions. The AI system generates ranked diagnostic outputs and associated confidence scores, which are compared with reference diagnoses and clinician performance metrics. The system is evaluated in an offline research environment. AI outputs are not used for clinical decision-making, patient management, or real-world medical care.

Primary outcome measure

  • Top-1 Diagnostic Accuracy [ Time Frame: At completion of diagnostic evaluations (up to 6 months) ]

Central Contacts and Locations

Central contacts

Locations

Nolla Health (Magic Health Inc.)

Recruiting

New York, New York, United States, 10003

Contacts

Principal Investigator:

Luis R Soenksen, MSE, PhD

More Information

Sponsor

Magic Health Inc. (d.b.a. Nolla Health)

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • Artificial Intelligence
  • Diagnostic Accuracy
  • Differential Diagnosis
  • Clinical Decision Support
  • Computer Vision
  • Medical Imaging
  • Multimodal AI
  • Physician Performance
  • Non-Inferiority
  • Diagnostic Reasoning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Magic Health Inc. (d.b.a. Nolla Health) on 2026-03-25.