Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT06980766
Eligibility Criteria:
Inclusion Criteria:
* Participants must be able to provide an informed consent or have legally authorized representative consent to participate.
* Participants that are between 7 and 17 years of age must provide assent to participate in the study.
* Participant must be willing and able to comply with the study procedures.
* Participant or legally authorized representative must be able to read or write in English.
* Participant must be 3 to 85 years of age.
* Participants must have an arm circumference in the range of 14-45 centimeters.
Exclusion Criteria:
* Participant is unwilling to provide informed consent.
* Participants with deformities or abnormalities that may prevent proper application of the device under test.
* Participants whose upper arm circumference is less than 14 cm or greater than 45 cm.
* Female participants who are self-reported as pregnant, or who are self-reported as trying to get pregnant.
* Participants with known heart arrhythmias.
* Participants with peripheral vascular disease.
* Participants with clotting disorders.
* History of bleeding disorders or personal history of prolonged bleeding from injury
* History of blood clots
* Hemophilia
* Participants that cannot tolerate sitting for up to 1 hour.
* Participant with a blood pressure demographic that has already been filled.
* Other known health conditions that will prevent safe participation in the study upon disclosure in health assessment form or verbally.
* Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
85 Years
Study:
NCT06980766
Study Brief:
Protocol Section:
NCT06980766