A Single-center, Open-label, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of a Statics Electricity Generator for Electric Stimulation Home Use(CGM MEPC_2401) for Improving Blood Circulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change and percent change in blood flow of the dorsal metacarpal vein
研究概览
简要总结
This study is a single-center, open-label, exploratory clinical trial to evaluate the safety and efficacy of a statics electricity generator for improving blood circulation.
详细描述
This clinical trial is conducted to evaluate the efficacy and safety of the personal electro-potential generator, CGM MEPC-2401, on the improvement of blood circulation in healthy adult subjects by applying the investigational medical device, the Ceragem Celtron Circulation Chair (CGM MEPC-2401).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 19 and 65 years
- •Individuals with a BMI of 30.0 kg/m² or less
- •Individuals without abnormal findings on hematology tests (CBC)
排除标准
- •Patients with uncontrolled hypertension despite medication (defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg measured at rest)
- •Patients with medical conditions requiring the use of assistive devices (e.g., pacemaker, artificial joint, stent, prosthesis, etc.)
- •Patients with seizure disorders or a history of loss of consciousness (e.g., epilepsy, acute febrile convulsions such as those associated with severe fever, etc.), or those at high risk of electric shock due to such conditions
- •Patients with ventricular arrhythmias (e.g., ventricular tachycardia, history of coronary artery bypass surgery, etc.) and patients with neurological disorders (e.g., diabetic neuropathy, etc.)
研究组 & 干预措施
CGM MEPC-2401
干预措施: CERAGEM CELLTRON CIRCULATION CHAIR (CGM MEPC-2401) (Device)
结局指标
主要结局
Change and percent change in blood flow of the dorsal metacarpal vein
时间窗: from baseline to immediately after a 30-minute application of the investigational device
Change and percent change in blood flow of the dorsal metacarpal vein from baseline to immediately after a 30-minute application of the investigational device
次要结局
- Change and percent change in capillary diameter assessed by capillary microscopy(from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes))
- Change and percent change in oxygen saturation (SpO₂)(from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes))
- Change and percent change in blood zeta potential, cellular ATP levels, nitric oxide, membrane potential, and matrix metalloproteinases(from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes))