Actively Recruiting
Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device
Led by Seoul National University Hospital · Updated on 2026-02-06
190
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
A
AIRS Medical Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults aged 19 years or older at the time of study enrollment.
- Able to undergo venipuncture in the antecubital area of both arms without restriction of elbow joint movement.
- Able to keep the arm in a stable extended position during venipuncture.
- Received full explanation of the study, understand the contents, voluntarily agree to participate, and provide written informed consent prior to screening.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Subjects with an implanted defibrillator or pacemaker.
- Increased bleeding risk due to anticoagulants, hemophilia, thrombocytopenia, preeclampsia, or other coagulation disorders.
- Abnormal vascular anatomy in the antecubital area from malformations, disease, or prior arteriovenous shunt.
- Significant abnormal skin lesions such as infection, dermatologic disease, trauma, or wounds in the antecubital area.
- Unsuitable arm condition for venipuncture due to transfusion, intravenous fluid therapy, or similar.
- Immunodeficiency or immunosuppression including steroid or immunosuppressant therapy or severe infection.
- Prior severe vasovagal reaction during venipuncture.
- Upper arm circumference over 44 cm preventing device tourniquet application.
- Conflict of interest such as employment with competing companies.
- Investigator judgment deeming participant unsuitable for the trial.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
Actively Recruiting
Research Team
D
Dahee Park
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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