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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT05756933
Eligibility Criteria:
Inclusion Criteria:
* Age \>= 20 years
* Ease of access to the hand used for the ArteVu device during the one-hour it is being used during the operation.
* Able to provide written informed consent for participation in the study.
Exclusion Criteria:
* Pregnant patients.
* Medical or surgical condition that prevents the ability to apply the ArteVu device on an upper extremity finger for a period of one-hour during anesthesia and operation.
* Impaired skin integrity of the fingers (e.g. injuries to the finger, burn injuries, or skin graft surgery on the finger).
* Operations involving the upper extremities or the blood vessels of the upper extremities.
* Arthritis or severe deformities of the hand and fingers
* Prosthetic devices or jewelry (such as a wedding band) that cannot be removed from the finger to be used for the ArteVu device.
* History of malignant hyperthermia
* Raynaud's disease affecting the fingers or hands.
* Topical allergy to ABS or silicone
* Swelling, edema or lymphedema of the upper extremity
* Participants with upper extremity occlusive peripheral vascular diseases
* Inability of the patient to provide written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT05756933
Study Brief:
Protocol Section:
NCT05756933