Electric Stimulation Home Use(CGM MEPC_2401) for Improving Blood Circulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CERAGEM CELLTRON CIRCULATION CHAIR (CGM MEPC-2401).
- Who it may be relevant to
- Registry conditions: Improving Blood Circulation, Blood Circulation. Basic parameters: 19 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Device CERAGEM CELLTRON CIRCULATION CHAIR (CGM MEPC-2401)
Improving blood circulation device (Ceragem Celltron Circulation Chair)
Primary outcome measures
- Change and percent change in blood flow of the dorsal metacarpal vein [Time frame: from baseline to immediately after a 30-minute application of the investigational device]
Secondary outcome measures (3)
- Change and percent change in capillary diameter assessed by capillary microscopy [Time frame: 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) [Time frame: 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 [Time frame: from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)]
Eligibility criteria
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Wonju Severance Christian Hospital — Wŏnju
Identifiers
NCT: NCT07446088 · CG03-KR25BLC101