电刺激家庭使用(CGM MEPC_2401)改善血液循环
一项单中心、开放标签、探索性临床试验，旨在评估用于家庭电刺激的静电场发生器（CGM MEPC_2401）改善血液循环的安全性和有效性
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.
研究概览
详细说明
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).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Wŏnju、韩国
- Wonju Severance Christian Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：CGM MEPC-2401
|
Improving blood circulation device (Ceragem Celltron Circulation Chair) |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change and percent change in blood flow of the dorsal metacarpal vein
大体时间：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 |
from baseline to immediately after a 30-minute application of the investigational device
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change and percent change in capillary diameter assessed by capillary microscopy
大体时间：from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)
|
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) |
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)
大体时间：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) |
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
大体时间：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) |
from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)
|
合作者和调查者
调查人员
- 首席研究员：Kwang Yong Shim, MD、Wonju Severance Christian Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CG03-KR25BLC101
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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