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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- First-attempt venipuncture success rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Test (device-assisted venipuncture) Arm
Participants will undergo venipuncture assisted by the AI- and ultrasound-based medical device (AIIV L2).
干预措施: AIIV L2 (Device)
Control (manual venipuncture) Arm
Participants will undergo venipuncture using the standard manual venipuncture technique.
干预措施: Manual venipuncture (Procedure)
结局指标
主要结局
First-attempt venipuncture success rate
时间窗: 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.
次要结局
- Procedure time(During each venipuncture procedure)
- Hemolysis Rate(Assessed by analyzing the blood samples obtained after venipuncture.)
- Pain score during device-assisted venipuncture (NRS)(Immediately after device-assisted venipuncture)
- Comparative pain assessment versus manual venipuncture(Immediately after completion of both venipuncture procedures)
- Acceptability of device-assisted venipuncture(Immediately after completion of both venipuncture procedures)
- Incidence of venipuncture-related adverse events(Immediately after venipuncture and during the short-term observation period)