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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM MEPC-2401 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CERAGEM CELLTRON CIRCULATION CHAIR (CGM MEPC-2401) | Device | Improving blood circulation device (Ceragem Celltron Circulation Chair) |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myeongbae Shin, Researcher | Contact | 82-10-4373-2808 | mbshin94@ceragem.com |
| Name | Affiliation | Role |
|---|---|---|
| Kwang Yong Shim, MD | Wonju Severance Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | South Korea |
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| 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) |