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Completed

NCT Number: NCT07383870

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

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.

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Key information

Conditions

Venipuncture

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AIIV L2

Device

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.

Manual venipuncture

Procedure

Venipuncture will be performed manually according to standard clinical practice, without use of the investigational device.

Primary outcomes

  1. First-attempt venipuncture success rate

    Time frame: Immediately after venipuncture

    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.

Secondary outcomes

  1. Procedure time

    Time frame: During each venipuncture procedure

    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.

  2. Hemolysis Rate

    Time frame: Assessed by analyzing the blood samples obtained after venipuncture.

    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.

  3. Pain score during device-assisted venipuncture (NRS)

    Time frame: Immediately after device-assisted venipuncture

    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).

  4. Comparative pain assessment versus manual venipuncture

    Time frame: Immediately after completion of both venipuncture procedures

    Participants subjectively compare pain experienced during device-assisted venipuncture relative to manual venipuncture, categorized as "less painful," "similar," or "more painful."

  5. Acceptability of device-assisted venipuncture

    Time frame: Immediately after completion of both venipuncture procedures

    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.

  6. Incidence of venipuncture-related adverse events

    Time frame: Immediately after venipuncture and during the short-term observation period

    Incidence of adverse events related to venipuncture assessed immediately after the procedure and during the short-term observation period.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • AIRS Medical Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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