AI- and ultrasound-assisted device to help with blood draws (AIIV L2)
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
This study tests whether an AI- and ultrasound-guided device (AIIV L2) helps adults get blood drawn more successfully on the first attempt compared with the usual manual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT07383870 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, crossover, open-label non-inferiority trial compares venipuncture using the AIIV L2 device with standard manual venipuncture. Each participant has blood drawn from both arms, with random assignment determining which arm uses the device and which uses the manual method, and the same operator performs both procedures. The primary endpoint is first-attempt venipuncture success, and secondary outcomes include procedure time, pain, hemolysis, and safety monitored by vital signs and adverse event reporting. Data will be collected prospectively to confirm the safety and efficacy of the AI- and ultrasound-based device.
Who should consider this trial
Good fit: Adults aged 19 years or older who can have venipuncture in the antecubital area of both arms, can keep the arm extended, and can provide informed consent are eligible.
Not a fit: People who are pregnant or breastfeeding, have implanted pacemakers/defibrillators, bleeding or coagulation disorders, abnormal antecubital vascular anatomy, or cannot undergo bilateral antecubital venipuncture are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could increase first-attempt success rates, shorten procedure time, and reduce pain and complication risk during venipuncture.
How similar studies have performed: Ultrasound-guided and vein-finder devices have shown promise in improving vascular access in other studies, though combining real-time ultrasound with AI guidance is a newer approach with limited confirmatory data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Seoul, Seoul
- Seoul National University Hospital — Seoul, Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Sang Hoon Song, MD, PhD — Seoul National University Hospital / Seoul National University College of Medicine
- Study coordinator: Dahee Park
- Email: park.dahee@airsmed.com
- Phone: +82 10 7612 0308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.