Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed No phase listed Observational

A Repeatability and Reproducibility Study of the EarliPoint™ Device

ClinicalTrials.gov ID: NCT04860986

Public ClinicalTrials.gov record NCT04860986. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 7:06 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04860986
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
EarliTec Diagnostics, Inc
Industry
Enrollment
45 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
16 Months to 30 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 6, 2021
Primary completion
Nov 16, 2021
Completion
Nov 16, 2021
Last update posted
Nov 7, 2023

2021

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Emory University Atlanta Georgia 30329

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04860986, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 7, 2023 · Synced Sep 8, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04860986 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →