Back to resultsCognoa ASD Diagnosis Aid Validation Study
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognoa ASD diagnostic device
Sponsored by
About this trial
This is an interventional diagnostic trial for Autism Spectrum Disorder
Eligibility Criteria
General 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
General 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.
Sites / Locations
- Melmed Center
- The Nicholls Group
- Orange County Child Neurology
- Pediatric Neurology of Orange County
- Private Practice
- Private Practice
- Private Practice
- MediSync Clinical Research Hattiesburg Clinic
- PriMed Clinical Research
- ARC Clinical Research at Wilson Parke
- ARC Clinical Research William Cannon
- ARC Clinical Research Kelly Lane
- Texas Child Neurology
- Private Practice
- Seattle Children's Hospital
- Multicare Health System - Mary Bridge Pediatrics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognoa Assessment
Arm Description
Cognoa diagnostic ASD device.
Outcomes
Primary Outcome Measures
Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation
Achievement of a composite of positive predictive value (PPV) greater than 65% and negative predictive value (NPV) greater than 85% for the device in relation to the clinical reference standard in the overall study population:
No Result Percentage
Measurement of the percentage of children for whom the device has provided no result.
Secondary Outcome Measures
Device Sensitivity and Specificity
Sensitivity and Specificity of the device in relation to the clinical reference standard in the overall study population.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04151290
Brief Title
Cognoa ASD Diagnosis Aid Validation Study
Official Title
Cognoa ASD Diagnosis Aid Validation Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
June 5, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cognoa, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will undergo both investigational and comparator diagnosis for ASD.
Masking
None (Open Label)
Masking Description
All participants and healthcare providers will be blinded to the diagnosis results.
Allocation
N/A
Enrollment
711 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognoa Assessment
Arm Type
Experimental
Arm Description
Cognoa diagnostic ASD device.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cognoa ASD diagnostic device
Intervention Description
Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)
Primary Outcome Measure Information:
Title
Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation
Description
Achievement of a composite of positive predictive value (PPV) greater than 65% and negative predictive value (NPV) greater than 85% for the device in relation to the clinical reference standard in the overall study population:
Time Frame
6 Weeks
Title
No Result Percentage
Description
Measurement of the percentage of children for whom the device has provided no result.
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Device Sensitivity and Specificity
Description
Sensitivity and Specificity of the device in relation to the clinical reference standard in the overall study population.
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
General 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
General 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharief Taraman, MD
Organizational Affiliation
Cognoa, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Melmed Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
The Nicholls Group
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Orange County Child Neurology
City
Laguna Niguel
State/Province
California
ZIP/Postal Code
92677
Country
United States
Facility Name
Pediatric Neurology of Orange County
City
Laguna Niguel
State/Province
California
ZIP/Postal Code
92677
Country
United States
Facility Name
Private Practice
City
Laguna Niguel
State/Province
California
ZIP/Postal Code
92677
Country
United States
Facility Name
Private Practice
City
Los Angeles
State/Province
California
ZIP/Postal Code
90034
Country
United States
Facility Name
Private Practice
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
MediSync Clinical Research Hattiesburg Clinic
City
Petal
State/Province
Mississippi
ZIP/Postal Code
39465
Country
United States
Facility Name
PriMed Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
ARC Clinical Research at Wilson Parke
City
Austin
State/Province
Texas
ZIP/Postal Code
78726
Country
United States
Facility Name
ARC Clinical Research William Cannon
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
ARC Clinical Research Kelly Lane
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Texas Child Neurology
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Private Practice
City
Seattle
State/Province
Washington
ZIP/Postal Code
98103
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Multicare Health System - Mary Bridge Pediatrics
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
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Cognoa ASD Diagnosis Aid Validation Study
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