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Cognoa ASD Diagnosis Aid Validation Study

NCT04151290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 711

Last updated 2021-12-28

Study results available
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Summary

The primary objective of this study is to collect data to ascertain the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa diagnostic device.

Conditions

Interventions

DIAGNOSTIC_TEST

Cognoa ASD diagnostic device

Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)

Sponsors & Collaborators

  • Cognoa, Inc.

    lead INDUSTRY

Principal Investigators

  • Sharief Taraman, MD · Cognoa, Inc.

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
2019-08-07
Primary Completion
2020-06-05
Completion
2020-08-31
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 NCT04151290 on ClinicalTrials.gov