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Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting

NCT05223374 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2024-02-08

No results posted yet for this study

Summary

This is a collaborative study that will provide a comprehensive source of observational data that can be used to obtain real world evidence of ASD. The study will contain demographic and observational clinical data for eligible participants. All decisions regarding patient care will be determined by the ECHO Autism Clinician (EAC). All clinical outcomes will be assessed by the EAC as would occur in routine clinical practice.

Conditions

  • Children18-72 Months With a Suspicion Autistic Disorder

Interventions

DEVICE

Canvas Dx

Canvas Dx is intended for use by healthcare providers as an aid in the diagnosis of autism spectrum disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider. The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process. The device is for prescription use only (Rx only)

Sponsors & Collaborators

  • University of Missouri-Columbia

    collaborator OTHER

  • Cognoa, Inc.

    lead INDUSTRY

Principal Investigators

  • Kristin Sohl, MD · University of Missouri-Columbia

Eligibility

Min Age
18 Months
Max Age
72 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-02-04
Completion
2024-02-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223374 on ClinicalTrials.gov