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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT05482035
Eligibility Criteria:
Inclusion Criteria:
1. Subjects should voluntarily participate in the clinical trial and sign the informed consent form.
2. Subjects must be willing and able to follow the investigation procedures.
3. Subjects are over 18 years old whose wrist circumference should be within 13.0-20.0 cm.
Exclusion Criteria:
1. Subjects with serious arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, borderline tachycardia, sinus arrest, pathological sinus syndrome, pacemaker rhythm) showed by electrocardiogram during screening period.
2. Subject with prior allergy to nylon, fluororubber, thermoplastic polyurethane elastomer (TPU), or polyvinyl chloride (PVC) materials.
3. Subjects with prior arterial obstructive disease or arteritis.
4. Subjects who had previously undergone mastectomy.
5. Subjects with wound or wrist inflammation were measured.
6. Subjects who are receiving intravenous infusion, blood transfusion, or other catheters at the site of measurement.
7. Subjects who had eaten, drank, smoked or exercised vigorously in the 30 minutes prior to the study.
8. Subjects who have participated in other clinical trials within 30 days that may affect this trial.
9. Subjects who the investigator consider inappropriate to attend the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05482035
Study Brief:
Protocol Section:
NCT05482035