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Clinical Trial 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 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.


Clinical Trial 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, 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04860986
Study type Observational
Source EarliTec Diagnostics, Inc
Contact Yunlong zhang
Phone 6692039308
Email [email protected]
Status Not yet recruiting
Phase
Start date April 30, 2021
Completion date October 30, 2021

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