Electric Stimulation Home Use(CGM MEPC_2401) for Improving Blood Circulation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Circulation; Improving Blood Circulation
• Intervention / Treatment: Device: CERAGEM CELLTRON CIRCULATION CHAIR (CGM MEPC-2401)

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).

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Myeongbae Shin, Researcher; Phone Number: 82-10-4373-2808; Email: mbshin94@ceragem.com

Study Locations

• South Korea
  • Wŏnju, South Korea
    • Recruiting
    • Wonju Severance Christian Hospital
    • Contact: Kwang Yong Shim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM MEPC-2401	Device: CERAGEM CELLTRON CIRCULATION CHAIR (CGM MEPC-2401); Improving blood circulation device (Ceragem Celltron Circulation Chair)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	from baseline to immediately after a 30-minute application of the investigational device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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	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)

Collaborators and Investigators

• Sponsor: Ceragem Clinical Inc.
• Investigators: Principal Investigator: Kwang Yong Shim, MD, Wonju Severance Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: blood circulation
• Other Study ID Numbers: CG03-KR25BLC101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No