A Repeatability and Reproducibility Study of the EarliPoint™ Device

Study Overview
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Brief Summary
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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 clinically-positive and clinically-negative for ASD. The study will be conducted at a single center in the US. The Study consists of a screening period in order to review the subject's medical history to determine subject eligibility, followed by a device administration period during which subjects will undergo testing with the EarliPoint Devices and Expert Clinician Diagnosis (ECD) procedures to determine if they are clinically-positive or clinically-negative for ASD.

Detailed Description
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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, for a total of six (6) measurements per endpoint for each subject enrolled. The order in which the subjects receive testing with each device will be randomized so that the same device is not always used first or last for each subject. The primary objectives of this study are to quantify the repeatability variability and reproducibility variability of all of the EarliPoint device's continuous valued outputs: the underlying continuous score used to classify patients into the binary diagnostic classification of either clinically-positive or clinically-negative for autism spectrum disorder (ASD) as well as each of the three EarliPoint Device severity scores (the social disability index, verbal ability index, and nonverbal ability index). The secondary objectives of this study are to quantify the repeatability and reproducibility variability in producing each of the three EarliPoint Device severity scores: the social disability index, verbal ability index, and nonverbal ability index.

Official Title
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A Repeatability and Reproducibility Study of the EarliPoint™ Device in Pediatric Subjects 16-30 Months of Age

Conditions
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Autism Spectrum Disorder (ASD)

Intervention / Treatment
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* Device: EarliPoint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 16 Months
Maximum Age: 30 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EarliPoint|EarliPoint is a non-invasive diagnostic device for ASD|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The EarliPoint Device repeatability | EarliPoint Device repeatability agreement in producing binary diagnostic outcomes (clinically-positive or negative for ASD) between multiple measurements per subject conducted with the same device (i.e., intra-device agreement);classification of either clinically-positive or clinically-negative for autism spectrum disorder (ASD) as well as each of the three EarliPoint Device severity scores (the social disability index, verbal ability index, and nonverbal ability index). | Anticipated in about 6 months | 
| The EarliPoint Device reproducibility | EarliPoint Device reproducibility agreement in producing binary diagnostic outcomes (clinically-positive or negative for ASD) between single measurements per subject conducted with multiple devices (i.e., inter-device agreement); | Anticipated in about 6 months | 
| The repeatability variance of the underlying EarliPoint Device | Repeatability variance of the underlying EarliPoint Device ASD presence metric (this metric is a continuous score underlying the binary diagnostic outcome: values less than or equal to 0 indicate a patient has ASD [clinically-positive], values greater than 0 indicate a patient does not have ASD [clinically-negative]); | Anticipated in about 6 months | 
| The reproducibility variance of the underlying EarliPoint Device | reproducibility variance of the underlying EarliPoint Device ASD presence metric (this metric is a continuous score underlying the binary diagnostic outcome: values less than or equal to 0 indicate a patient is ASD positive, values greater than 0 indicate a patient is ASD negative). | Anticipated in about 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EarliPoint, Pediatric, Diagnosis