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

Purpose: This study aims to confirm the safety and efficacy of AIIV L2, an artificialintelligence‐ and ultrasound‐based medical device that assists venipuncture, by comparingvenipuncture 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 theother arm using manual venipuncture, according to randomized allocation. Aftervenipuncture is performed on both arms, outcomes including venipuncture success rate,procedure time, pain, and hemolysis will be evaluated. All venipuncture procedures willbe performed by the same operator. Vital signs and adverse events will be monitoredbefore and after the procedure.‐ Primary Efficacy EndpointVenipuncture success rate:Comparison of the success rate of venipuncture on the first attempt between AI‐assistedvenipuncture and manual venipuncture.‐ Secondary Efficacy EndpointsProcedure 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 sameparticipant.Acceptability:Participant satisfaction and preference regarding AI‐assisted venipuncture, assessedusing a structured questionnaire.