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.

Study Overview

• Status: Completed
• Conditions: Venipuncture
• Intervention / Treatment: Device: AIIV L2; Procedure: Manual venipuncture

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test (device-assisted venipuncture) Arm; Participants will undergo venipuncture assisted by the AI- and ultrasound-based medical device (AIIV L2).	Device: AIIV L2; The investigational device is AIIV L2 (product code: H2BXXA2), an AI- and ultrasound-based medical device designed to assist venipuncture. This medical device is intended for use by healthcare professionals in medical institutions to obtain ultrasound images of the antecubital area of adult subjects, utilize an artificial intelligence model to identify the location of veins, and determine the insertion site of the needle to assist with venipuncture.
Active Comparator: Control (manual venipuncture) Arm; Participants will undergo venipuncture using the standard manual venipuncture technique.	Procedure: Manual venipuncture; Venipuncture will be performed manually according to standard clinical practice, without use of the investigational device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-attempt venipuncture success rate	First-attempt venipuncture success is defined as successful collection of at least 1 mL of blood into a collection tube at the first needle insertion into the participant's arm.	Immediately after venipuncture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	Procedure time is defined as the duration that directly affects the participant. The measurement start time is defined as the moment of first direct contact with the participant after completion of subject verification and preparation of consumables. For device-assisted venipuncture, the start time is defined as the time point at which the "search start" button is pressed and the tourniquet is automatically applied. For manual venipuncture, the start time is defined as the earlier of the time point when the tourniquet is applied by the operator or when the operator begins palpation of the vein. For both methods, the measurement end time is defined as the time point at which venipuncture is completed and hemostasis is initiated.	During each venipuncture procedure
Hemolysis Rate	Hemolysis is objectively assessed for all collected blood samples using an automated hemolysis index. Hemolysis is defined as a hemoglobin concentration greater than 0.5 g/L.	Assessed by analyzing the blood samples obtained after venipuncture.
Pain score during device-assisted venipuncture (NRS)	Pain intensity experienced by participants during device-assisted venipuncture is assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).	Immediately after device-assisted venipuncture
Comparative pain assessment versus manual venipuncture	Participants subjectively compare pain experienced during device-assisted venipuncture relative to manual venipuncture, categorized as "less painful," "similar," or "more painful."	Immediately after completion of both venipuncture procedures
Acceptability of device-assisted venipuncture	Acceptability of device-assisted venipuncture is assessed by asking participants whether they would be willing to undergo venipuncture using the device again in the future.	Immediately after completion of both venipuncture procedures
Incidence of venipuncture-related adverse events	Incidence of adverse events related to venipuncture assessed immediately after the procedure and during the short-term observation period.	Immediately after venipuncture and during the short-term observation period

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: AIRS Medical Inc.
• Investigators: Principal Investigator: Sang Hoon Song, MD, PhD, Seoul National University Hospital / Seoul National University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Actual): February 12, 2026
• Study Completion (Actual): February 12, 2026

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; Artificial Intelligence; Venipuncture; Medical device; Phlebotomy; Vascular access
• Other Study ID Numbers: AM-AIIV-2501; 2511-143-1698 (Other Identifier: IRB of Seoul National University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No