CompletedNot Applicable

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

South Korea190 participantsStarted 2026-01-26

Plain-language 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 circu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

First-attempt venipuncture success rate

Timeframe: Immediately after venipuncture

Trial details

NCT IDNCT07383870

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-12

View on ClinicalTrials.gov More Venipuncture trials