Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device

A Single-Center, Randomized, Crossover, Prospective, Open-Label, Non-Inferiority Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of an AI- and Ultrasound-Based Medical Device That Assists Venipuncture, Compared With Manual Venipuncture

Purpose

: This study aims to confirm the safety and efficacy of AIIV L2, an artificial intelligence- and ultrasound-based medical device that assists venipuncture, by comparing venipuncture performed using AIIV L2 with manual venipuncture.

Study Design : This is a single-center, randomized, crossover, prospective, open-label, non-inferiority confirmatory clinical trial.

Methods

: Each participant will undergo venipuncture on both arms: one arm using AIIV L2 and the other arm using manual venipuncture, according to randomized allocation. After venipuncture is performed on both arms, outcomes including venipuncture success rate, procedure time, pain, and hemolysis will be evaluated. All venipuncture procedures will be performed by the same operator. Vital signs and adverse events will be monitored before and after the procedure.

- Primary Efficacy Endpoint

Venipuncture success rate:

Comparison of the success rate of venipuncture on the first attempt between AI-assisted venipuncture and manual venipuncture.

- Secondary Efficacy Endpoints

Procedure time:

Time from needle insertion to completion of venipuncture.

Hemolysis rate:

Presence of hemolysis in collected samples, determined according to laboratory criteria.

Pain score (NRS):

Numeric Rating Scale (0-10) reported by participants after each venipuncture method.

Within-subject pain comparison:

Comparison of pain scores between AI-assisted and manual venipuncture within the same participant.

Acceptability:

Participant satisfaction and preference regarding AI-assisted venipuncture, assessed using a structured questionnaire.

Inclusion Criteria:

• 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:

• 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.