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

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.

NCT Number	NCT07383870
Lead Sponsor	Seoul National University Hospital Collaborators: AIRS Medical Inc.
Conditions	Venipuncture
Enrollment	190 participants
Start Date	2026-01-26
Primary Completion	2026-02-12 (estimated)
Study Completion	2026-02-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-28