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Cognoa ASD Diagnostic Device - Data Collection Study

NCT03871179 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-02-08

No results posted yet for this study

Summary

The primary objective of this study is to collect data to ascertain the PPV and NPV of the current version of the Cognoa diagnostic device. A secondary objective is to collect data, in the form of additional questions, in order to train new algorithms related to children's developmental and behavioral conditions.

Conditions

Interventions

DIAGNOSTIC_TEST

ASD Diagnostic Device

The ASD Diagnostic Device is a machine learning algorithm-based software as a medical device that is incorporated into a parent/caregiver-facing mobile application, the "Cognoa App", used outside of a clinical setting

Sponsors & Collaborators

  • Cognoa, Inc.

    lead INDUSTRY

Principal Investigators

  • Tom Megerian, MD · Children's Hospital of Orange County

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-01-23
Primary Completion
2019-08-12
Completion
2019-08-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03871179 on ClinicalTrials.gov