Cognoa ASD Diagnostic Device - Data Collection Study

NCT03871179 | Withdrawn FDA Device

• 1 other identifier: 1189568
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Positive and negative predictive value of ASD Dx in relation to clinician diagnostic evaluation

  approximately one month

Study Arms (1)

ASD Diagnostic Device

OTHER

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

Diagnostic Test: ASD Diagnostic Device

Interventions

ASD Diagnostic Device DIAGNOSTIC_TEST

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

ASD Diagnostic Device

Eligibility Criteria

• Age: 18 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≥ 18 months of age and \< 72 months of age
• Functional English capability in the home environment
• Documented parental and/or clinician concern for developmental delay
• Participants must have a smartphone capable of downloading the Cognoa App (Cognoa supports iOS 10.0 and up, Android 6.0 and up)

You may not qualify if:

• Children with suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia.
• Children with known sensory impairment such as deafness or blindness
• Children with known physical impairment affecting their ability to use their hands
• Children with major dysmorphic features or prenatal exposure to teratogens (such as fetal alcohol syndrome)
• Children with history or diagnosis of genetic conditions (such as Rett's syndrome or fragile X)
• Children with microcephaly
• Children with history or prior diagnosis of epilepsy or seizures
• Children with history of or suspected neglect
• Children with history of brain defect, injury or insult requiring interventions such as surgery or chronic medication
• Children whose age on the date of enrollment is outside the target age range
• Children who have been previously enrolled in any Cognoa clinical study or survey
• Children whose medical records had been included in any internal Cognoa training or validation sets

Sponsors & Collaborators

• Cognoa, Inc.: lead

Study Sites (1)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Tom Megerian, MD

  Children's Hospital of Orange County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants, care providers, and diagnostic clinicians are blinded to the diagnostic output of the ASD diagnostic device
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 12, 2019
• Study Start: January 23, 2019
• Primary Completion: August 12, 2019
• Study Completion: August 12, 2019
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)