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:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT01485120
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide written informed consent or have a legally authorized representative provide written informed consent
* Any volunteer subjects ≥ 18 years of age
* Subject must have the presence of normal sinus rhythm on ECG
* Subject will return for follow-up visit from 5 days to 8 days after study procedure
Exclusion Criteria:
* Any subject who is unable to provide written informed consent
* Any subject with the presence of peripheral vascular disease in either arm
* Any subject that demonstrates an initial NIBP screening for a blood pressure distribution range that has already been filled.
* Any subject who cannot tolerate 21 repeated BP measurements
* Any subjects with clotting or bleeding disorders
* Any subjects taking medications that are considered anticoagulants or blood thinners (For example, Clopidogrel, Warfarin, Dipyridamole, Aspirin, and Enoxaparin)
* Any subject who is unable to have arterial line placed in the radial artery
* Any subject that cannot tolerate 4 fast flushes for the frequency response
* Any female subjects pregnant or lactating
* Any subject that has previously participated in this study
* Any subjects that cannot return 5 to 8 days post study procedure for a follow-up visit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01485120
Study Brief:
Protocol Section:
NCT01485120