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

NCT07383870 | Recruiting

• 2 other identifiers: AM-AIIV-25012511-143-1698
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venipuncture

Keywords

Venipuncture; Ultrasound; Artificial Intelligence; Medical device; Vascular access; Phlebotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Procedure time

  During each venipuncture procedure

• Hemolysis Rate

  Assessed by analyzing the blood samples obtained after venipuncture.

• Pain score during device-assisted venipuncture (NRS)

  Immediately after device-assisted venipuncture

• Comparative pain assessment versus manual venipuncture

  Immediately after completion of both venipuncture procedures

• Acceptability of device-assisted venipuncture

  Immediately after completion of both venipuncture procedures

Study Arms (2)

Test (device-assisted venipuncture) Arm

ACTIVE COMPARATOR

Participants will undergo venipuncture assisted by the AI- and ultrasound-based medical device (AIIV L2).

Device: AIIV L2

Control (manual venipuncture) Arm

ACTIVE COMPARATOR

Participants will undergo venipuncture using the standard manual venipuncture technique.

Procedure: Manual venipuncture

Interventions

Manual venipuncture PROCEDURE

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

Control (manual venipuncture) Arm

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.

Test (device-assisted venipuncture) Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AIRS Medical Inc.: collaborator
• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

Study Officials

• Sang Hoon Song, MD, PhD

  Seoul National University Hospital / Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dahee Park

CONTACT

+82 10 7612 0308; park.dahee@airsmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This clinical trial is designed as a within-subject, randomized, crossover comparative study, in which the unit of comparison is not the subject but both arms (venipuncture sites) of each subject.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 3, 2026
• Study Start: January 26, 2026
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)