None listed
Conditions
Interventions
Medical Device : - Device name/model: AIIV L2
- Product code: H2BXXA2
- Intended use:
This medical device is intended for use by healthcare professionals in medical institutions to obtain ultrasound i
Sponsors
AIRS Medical Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Subjects who meet all of the following criteria will be included: - Male or female adults aged 19 years or older at the time of study enrollment. - Subjects who are able to undergo venipuncture in the antecubital area of both arms, without restriction of elbow joint movement, and who can maintain the arm in a stable extended position during venipuncture. - Subjects who have received a full explanation of the clinical trial, fully understand the contents, voluntarily decide to participate, and provide written informed consent prior to screening procedures.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Subjects who meet any of the following criteria will be excluded: - Pregnant or breastfeeding women. - Subjects with an implanted defibrillator or pacemaker. - Subjects at increased risk of bleeding due to underlying conditions such as anticoagulant use, hemophilia, thrombocytopenia, preeclampsia, or other coagulation disorders. - Subjects with abnormal vascular anatomy in the antecubital area due to vascular malformations, vascular disease, or prior creation of an arteriovenous shunt. - Subjects with significant abnormal skin lesions (e.g., infection, dermatologic disease, trauma, or wounds) in the antecubital area. - Subjects whose arm condition is unsuitable for venipuncture due to transfusion, intravenous fluid therapy, or similar procedures. - Subjects with immunodeficiency or immunosuppression (e.g., steroid or immunosuppressant therapy, severe infection) and therefore vulnerable to infection. - Subjects with a prior history of severe vasovagal reaction during venipuncture. - Subjects whose upper arm circumference exceeds 44 cm, preventing application of the tourniquet inside the device. - Subjects with a conflict of interest, such as employees of competing companies. - Subjects considered by the investigator to be otherwise unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Venipuncture success rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure time;Hemolysis rate;Pain score during device-assisted venipuncture (NRS);Within-subject comparison of pain scores between device-assisted venipuncture and manual venipuncture.;Assessment of participants’ willingness to undergo venipuncture again using the device.;Incidence of venipuncture-related adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Hoon Song
Seoul National University Hospital
Outcome results
None listed