VenipunctureNCT07383870
Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device
A study testing AIIV L2 and Manual venipuncture in people with Venipuncture, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venipuncture
- What is being tested?
- AIIV L2 and Manual venipuncture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jan 2026to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Crossover, Prospective, Open-Label, Non-Inferiority Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of an AI- and Ultrasound-Based Medical Device That Assists Venipuncture, Compared With Manual Venipuncture
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.
Read more
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
- Being tested
- AIIV L2, Manual venipuncture
- Keywords
- Venipuncture, Ultrasound, Artificial Intelligence, Medical device, Vascular access, Phlebotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIIV L2Device
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.
Manual venipunctureProcedure or surgery
Venipuncture will be performed manually according to standard clinical practice, without use of the investigational device.
| Study group | Role | What they receive |
|---|---|---|
| Test (device-assisted venipuncture) Arm | Active comparator | Participants will undergo venipuncture assisted by the AI- and ultrasound-based medical device (AIIV L2). Receives: Device: AIIV L2 |
| Control (manual venipuncture) Arm | Active comparator | Participants will undergo venipuncture using the standard manual venipuncture technique. Receives: Procedure: Manual venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after venipuncture
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 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."
Measured: 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.
Measured: 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.
Measured: Immediately after venipuncture and during the short-term observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start26 Jan 2026
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VenipunctureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AIRS Medical Inc.
- Responsible party
- Sponsor
- Investigators
- Sang Hoon Song, MD, PhD, Principal investigator, Seoul National University Hospital / Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383870
- Sponsor's protocol ID
- AM-AIIV-2501
- Other IDs
- 2511-143-1698
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Crossover, Prospective, Open-Label, Non-Inferiority Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of an AI- and Ultrasound-Based Medical Device That Assists Venipuncture, Compared With Manual Venipuncture
- ClinicalTrials.gov ID
- NCT07383870
- Acronym / sponsor ID
- AM-AIIV-2501
- Conditions
- Venipuncture
- Keywords
- Venipuncture, Ultrasound, Artificial Intelligence, Medical device, Vascular access, Phlebotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- AIRS Medical Inc.
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test (device-assisted venipuncture) Arm | Active comparator | Device: AIIV L2Participants will undergo venipuncture assisted by the AI- and ultrasound-based medical device (AIIV L2). |
| Control (manual venipuncture) Arm | Active comparator | Procedure: Manual venipunctureParticipants will undergo venipuncture using the standard manual venipuncture technique. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIIV L2The 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. | Device | Test (device-assisted venipuncture) Arm |
| Manual venipunctureVenipuncture will be performed manually according to standard clinical practice, without use of the investigational device. | Procedure or surgery | Control (manual venipuncture) Arm |
Primary outcome
First-attempt venipuncture success rate
Time frame: Immediately after venipuncture
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.
6 secondary outcomes
Procedure time
Time frame: During each venipuncture procedure
Hemolysis Rate
Time frame: Assessed by analyzing the blood samples obtained after venipuncture.
Pain score during device-assisted venipuncture (NRS)
Time frame: Immediately after device-assisted venipuncture
Comparative pain assessment versus manual venipuncture
Time frame: Immediately after completion of both venipuncture procedures
Acceptability of device-assisted venipuncture
Time frame: Immediately after completion of both venipuncture procedures
Incidence of venipuncture-related adverse events
Time frame: Immediately after venipuncture and during the short-term observation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Hoon Song, MD, PhD principal investigator
Seoul National University Hospital / Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIIV L2 and Manual venipuncture in people with Venipuncture, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-attempt venipuncture success rate (time frame: Immediately after venipuncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.