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 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT05977335
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (patients aged ≥ 18 years)
* Patients giving written informed consent to participate in the study.
* Patients with intact perfusion of both hands evidenced by a positive Allen's test.
* Patients with orthostatic intolerance will be included
Exclusion Criteria:
* Patients with vascular implants at the sites of non-invasive BP measurement (fingers or upper arms)
* Very low perfusion in the periphery
* Arterial vascular diseases (arteriosclerosis, Raynaud's syndrome, endarteritis obliterans, collagenosis, severely advanced vascular diseases (PAOD))
* Patients with significant edema in the fingers
* Patients with atrial fibrillation
* Patients with valvular disease of grade 2 or above
* Patients with ventricular assist devices
* Subjects not passing the Allen's test for both hands.
* Patients with a large lateral difference in BP (\> 15 mmHg for systolic BP and/or \>10 mmHg for diastolic BP) or with same arm measurement differences \> 10 mmHg in systolic or diastolic BP during assessment of lateral differences
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05977335
Study Brief:
Protocol Section:
NCT05977335