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

NCT07383870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-05-28

No results posted yet for this study

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

Interventions

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.

PROCEDURE

Manual venipuncture

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

Sponsors & Collaborators

  • AIRS Medical Inc.

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Sang Hoon Song, MD, PhD · Seoul National University Hospital / Seoul National University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-26
Primary Completion
2026-02-12
Completion
2026-02-12

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07383870 on ClinicalTrials.gov