Blood Circulation, Improving Blood Circulation
Conditions
Keywords
blood circulation
Brief summary
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.
Detailed description
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).
Interventions
DEVICECERAGEM CELLTRON CIRCULATION CHAIR (CGM MEPC-2401)
Improving blood circulation device (Ceragem Celltron Circulation Chair)
Sponsors
Ceragem Clinical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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) | 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) |
Countries
South Korea
Contacts
CONTACTMyeongbae Shin, Researcher
PRINCIPAL_INVESTIGATORKwang Yong Shim, MD
Wonju Severance Christian Hospital
Outcome results
None listed