Status:
COMPLETED
A Repeatability and Reproducibility Study of the EarliPoint™ Device
Lead Sponsor:
EarliTec Diagnostics, Inc
Conditions:
Autism Spectrum Disorder (ASD)
Eligibility:
All Genders
16-30 years
Brief Summary
The study is a prospective randomized repeatability and reproducibility (R\&R) study of the EarliPoint DeviceTM in pediatric subjects 16-30 months of age. The study will enroll subjects who are both c...
Detailed Description
Subjects will undergo testing with the same two (2) devices, with one (1) testing session per device per subject, with each testing session yielding three (3) measurements per endpoint per subject, fo...
Eligibility Criteria
Inclusion
- Children between 16 and 30 months of age.
- No acute illnesses by physical observation.
- Normal or corrected-to-normal vision, and normal or corrected-to-normal hearing.
- Communicate meaningfully with patent in English, and the principal investigator /the study team.
- Parent or legal guardian is able to read and understand the Informed Consent Form.
- Parent voluntarily provides written informed consent.
Exclusion
- Genetic disorders (e.g., Fragile X, Williams Syndrome, Tuberous Sclerosis, muscular Dystrophy, Neurofibromatosis, Down Syndrome).
- History or presence of a clinically significant medical disease or a mental state that might confound the study result as assessed by the investigator, such as severe hearing or visual impairment; or uncontrolled epilepsy or seizure disorder, et al.
- Acute exacerbations of chronic illnesses likely to prevent successful data collection.
- Receiving therapies that may affect vision.
- Therapies that may affect the ability to focus.
- Known allergies or sensitivity to the plastic, leather, or metal components.
- Unable or unwilling to sit in a child safety seat.
- Use of any investigational drug, therapies or diagnostic device within the past 14 days.
Key Trial Info
Start Date :
May 7 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 17 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04860986
Start Date
May 7 2021
End Date
November 17 2021
Last Update
November 8 2023
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30329