An observational study in Autism Spectrum Disorder (ASD), sponsored by EarliTec Diagnostics, Inc. Completed at 1 site in United States. Open to participants aged 16 Months to 30 Months. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by EarliTec Diagnostics, Inc · Observational
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.
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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's enrollment of 45 is below the median of 102 across 320 observational studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →EarliTec Diagnostics, Inc is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Toddlers and young children will be enrolled in this study, as the aim of this research is to examine repeatability of eye-tracking measures in children aged 16-30 months. Precautions will be taken when working with young children. Our clinicians and research staff are well trained and experienced in working with children and families with some level of anxiety.
All subject's parent or legal guardian will be consented to the study. No protocol-specific procedures, including screening, will be performed until the parent has signed and dated the consent form. Subjects will also satisfy the inclusion and exclusion criteria in order to be enrolled in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EarliPoint is a non-invasive diagnostic device for ASD
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).
Time frame: 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);
Time frame: 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 \[clinically-negative\]);
Time frame: 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).
Time frame: Anticipated in about 6 months
Plan to share: No — There is no plan to share individual participant data (IPD) to other researchers.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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EarliTec Diagnostics, Inc