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Cognoa ASD Diagnosis Aid Validation Study

NCT ID: NCT04151290

Last Updated: 2021-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

711 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-07

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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To assess the ability of the diagnostic device to aid in the diagnosis of ASD by comparing its diagnostic output with the clinical reference standard, consisting of a diagnosis made by a specialist clinician, based on DSM-5 criteria and validated by one or more reviewing specialist clinicians

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects will undergo both investigational and comparator diagnosis for ASD.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

All participants and healthcare providers will be blinded to the diagnosis results.

Study Groups

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Cognoa Assessment

Cognoa diagnostic ASD device.

Group Type EXPERIMENTAL

Cognoa ASD diagnostic device

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Cognoa ASD diagnostic device

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Caregiver must be able to read, understand and sign the Informed Consent Form (ICF).
* Caregiver or HCP concern for developmental delay.
* Female or Male, \>18 to \<72 months of age

Exclusion Criteria

* Subjects with a prior diagnosis of ASD rendered by a healthcare professional.
* Subjects whose age on the date of enrollment is outside the target age range.
* Subjects or caregivers who have been previously enrolled in any Cognoa clinical study or survey.
Minimum Eligible Age

18 Months

Maximum Eligible Age

72 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cognoa, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharief Taraman, MD

Role: STUDY_DIRECTOR

Cognoa, Inc.

Locations

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Melmed Center

Scottsdale, Arizona, United States

Site Status

The Nicholls Group

Scottsdale, Arizona, United States

Site Status

Orange County Child Neurology

Laguna Niguel, California, United States

Site Status

Pediatric Neurology of Orange County

Laguna Niguel, California, United States

Site Status

Private Practice

Laguna Niguel, California, United States

Site Status

Private Practice

Los Angeles, California, United States

Site Status

Private Practice

Palo Alto, California, United States

Site Status

MediSync Clinical Research Hattiesburg Clinic

Petal, Mississippi, United States

Site Status

PriMed Clinical Research

Dayton, Ohio, United States

Site Status

ARC Clinical Research at Wilson Parke

Austin, Texas, United States

Site Status

ARC Clinical Research William Cannon

Austin, Texas, United States

Site Status

ARC Clinical Research Kelly Lane

Pflugerville, Texas, United States

Site Status

Texas Child Neurology

Plano, Texas, United States

Site Status

Private Practice

Seattle, Washington, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Multicare Health System - Mary Bridge Pediatrics

Tacoma, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Q170886

Identifier Type: -

Identifier Source: org_study_id