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 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
NCT ID:
NCT06351761
Eligibility Criteria:
Inclusion Criteria:
* Male or female who are 22 years of age or older
* Subject able to read, understand, and provide written informed consent
* Subject willing and able to participate in the study procedures as described in the consent form
* Subject able to communicate effectively with and willing to follow instructions from the study staff
Exclusion Criteria:
* Subject with an implanted electrical device (i.e. pacemaker, ICD …), whether active or inactive
* Pathologic disorders that may affect motricity resulting in significant hands tremor that prevents subject from being able to hold still (e.g. Parkinson disease)
* Myocardial Infarction (MI) within 90 days prior to the enrollment
* Pulmonary embolism or pulmonary infarction within 90 days prior to the enrollment
* Stroke or Transient Ischemic Attack (TIA) within 90 days prior to the enrollment
* Active or history of life-threatening rhythms as determined by investigators (e.g. ventricular tachycardia, ventricular fibrillation, 3rd degree heart block)
* Any cardiovascular disease that investigators would consider as a risk to subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis)
* Active or symptomatic skin disease on Schiller electrode attachment sites or fingertips which would be in contact with BeamO electrodes (e.g. eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis)
* Known sensitivity to medical adhesives, isopropyl alcohol,, electrocardiogram (ECG) electrodes, including known allergy or sensitivity to stainless steel (used in BeamO electrodes).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06351761
Study Brief:
Protocol Section:
NCT06351761