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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT04100668
Eligibility Criteria:
Inclusion Criteria:
* General:
* Subject must have the ability to understand and provide written informed consent
* Subject must be willing and able to comply with study procedures and duration
* Screening and Phase 1:
* Subject is from 20 to 55 years old.
* Subject has wrist circumference size within 145 and 220mm for both arms.
* Subjects with lateral blood pressure difference (auscultatory cuff based measurement) is less than: 15 mmHg for systolic blood pressure. 10 mmHg for diastolic blood pressure.
* Subjects with investigational device signal quality higher than a predefined value
* Subjects with similar investigational devices signals between their two arms.
* Phase 2 (all requirements as Phase 1 except):
* Subject is from 20 to 85 years old.
* At least 60% of subjects will have hypertensive blood pressure values (goal) (systolic \>140 mmHg and/or diastolic \>90 mmHg)
* At least 15% of subjects will have hypotensive blood pressure values (goal) (systolic \<110 mmHg and/or diastolic \<60 mmHg).
* No more than 25% of subjects will have normotensive blood pressure values (goal) (systolic from 110 to 140 mmHg and/or diastolic from 60 to 90 mmHg).
Exclusion Criteria:
* Subject with a BMI over 39
* Deformities or abnormalities that may prevent proper application of the device under test
* Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
* Subjects with known respiratory conditions such as: (self-reported)
* uncontrolled / severe asthma,
* flu,
* pneumonia / bronchitis,
* shortness of breath / respiratory distress,
* respiratory or lung surgery,
* emphysema, COPD, lung disease
* Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
* have had cardiovascular surgery
* have cardiac pacemakers and/or automatic internal cardio-defibrillator
* Chest pain (angina)
* Abnormal pulse pressure
* previous heart attack
* blocked artery
* unexplained shortness of breath
* congestive heart failure (CHF)
* history of stroke
* transient ischemic attack
* carotid artery disease
* myocardial ischemia
* myocardial infarction
* cardiomyopathy
* Subject with a heart rate of less than 45 BPM
* Self-reported health conditions as identified in the Health Assessment Form (self- reported)
* diabetes,
* uncontrolled thyroid disease,
* kidney disease / chronic renal impairment,
* history of seizures (except childhood febrile seizures),
* epilepsy,
* history of unexplained syncope,
* recent history of frequent migraine headaches,
* recent head injury
* cancer / chemotherapy
* Subjects with known clotting disorders (self-reported)
* history of bleeding disorders or personal history of prolonged bleeding from injury
* history of blood clots
* hemophilia
* current use of blood thinner: prescription or daily use of aspirin
* Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
* Subjects with a contact allergy to ultrasound gel.
* Subjects with prior or known allergies to iodine or lidocaine (or similar pharmacological agents, e.g. Novocaine)
* Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test
* Subject is intoxicated during the time of the visit, or was intoxicated within 24 hours prior to study visit, as reported by the subject, or per study staff judgment.
* Other known health condition, should be considered upon disclosure in health assessment form
* Subjects with heart rate below 45 BPM.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT04100668
Study Brief:
Protocol Section:
NCT04100668