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A Repeatability and Reproducibility Study of the EarliPoint™ Device

NCT04860986 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2023-11-08

No results posted yet for this study

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.

Conditions

  • Autism Spectrum Disorder (ASD)

Interventions

DEVICE

EarliPoint

EarliPoint is a non-invasive diagnostic device for ASD

Sponsors & Collaborators

  • EarliTec Diagnostics, Inc

    lead INDUSTRY

Principal Investigators

  • Sew-Wah Tay · EarliTec Diagnostics, Inc

Eligibility

Min Age
16 Months
Max Age
30 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2021-11-17
Completion
2021-11-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04860986 on ClinicalTrials.gov