Electric Stimulation Home Use(CGM MEPC_2401) for Improving Blood Circulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorCeragem Clinical Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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.)
Trial design
Design model
Single group
Treatments tested in this trial
CERAGEM CELLTRON CIRCULATION CHAIR (CGM MEPC-2401)
DeviceImproving blood circulation device (Ceragem Celltron Circulation Chair)
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: CGM MEPC-2401Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change and percent change in blood flow of the dorsal metacarpal vein
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
Time frame
from baseline to immediately after a 30-minute application of the investigational deviceSecondary outcomes
1
Change and percent change in capillary diameter assessed by capillary microscopy
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)
Time frame
from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)2
Change and percent change in oxygen saturation (SpO₂)
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)
Time frame
from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)3
Change and percent change in blood zeta potential, cellular ATP levels, nitric oxide, membrane potential, and matrix metalloproteinases
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)
Time frame
from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov