An interventional study of AIIV L2 and Manual venipuncture in Venipuncture, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Supportive care
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo venipuncture assisted by the AI- and ultrasound-based medical device (AIIV L2).
Device: AIIV L2
Participants will undergo venipuncture using the standard manual venipuncture technique.
Procedure: Manual venipuncture
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.
Venipuncture will be performed manually according to standard clinical practice, without use of the investigational device.
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.
Time frame: Immediately after venipuncture
Procedure time
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.
Time frame: During each venipuncture procedure
Hemolysis Rate
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.
Time frame: Assessed by analyzing the blood samples obtained after venipuncture.
Pain score during device-assisted venipuncture (NRS)
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).
Time frame: Immediately after device-assisted venipuncture
Comparative pain assessment versus manual venipuncture
Participants subjectively compare pain experienced during device-assisted venipuncture relative to manual venipuncture, categorized as "less painful," "similar," or "more painful."
Time frame: Immediately after completion of both venipuncture procedures
Acceptability of device-assisted venipuncture
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.
Time frame: Immediately after completion of both venipuncture procedures
Incidence of venipuncture-related adverse events
Incidence of adverse events related to venipuncture assessed immediately after the procedure and during the short-term observation period.
Time frame: Immediately after venipuncture and during the short-term observation period
Plan to share: No
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Seoul National University Hospital