Cera-Flow: Blood Circulation Short Term Study
Study Details
Study Description
Brief Summary
The study is a single center clinical trial to evaluate the efficacy and safety of blood circulation improvement using an investigational medical device, which is a product on the market and it's name is Ceragem Master V6, for the risk group of Deep Vein Thrombosis (DVT) and the ordinary person. The study compares before and after the application by one time application.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The efficacy and safety evaluation are conducted before and after (or during) the application of the test device. The investigator shall apply an investigational device once when visiting a suitable subject for one day.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: blood circulation treatment Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT) and the ordinary person |
Device: Blood circulation device
Blood circulation device of CGM MB-1701 (Ceragem Master V6)
|
Outcome Measures
Primary Outcome Measures
- Peak Systolic Velocity (PSV) change [While 2 consecutive application (36 minutes) per one subject]
Evaluate the maximum blood flow rate (PSV) change in the femoral vein when applied compared to before application of the device using ultrasonic at Visit 1
Secondary Outcome Measures
- Antero-posterior (AP) diameter [While 2 consecutive application (36 minutes) per one subject]
Evaluate the the maximum AP diameter change of the femoral vein when applied compared to before the device is applied using ultrasonic at Visit 1.
- Cross Sectional Area [While 2 consecutive application (36 minutes) per one subject]
Evaluate the maximum CSA area change of the femoral vein when applied compare to before the device is applied using ultrasonic at Visti 1.
Eligibility Criteria
Criteria
Inclusion Criteria for all subjects; 1. Adult men and women over 19 years of age 2. Subjects who have not been diagnosed with deep vein thrombosis in the lower extremities through the following test results prior to the application of medical devices.
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Subjects diagnosed by Doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea
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D-dimer negative test result
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Subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent
Additional Inclusion Critetia for the DVT risk subjects;
- Subjects have two or more points of venous thromboembolism (hereinafter referred to as VTE) clinical prediction score (Two-level wells scroe) at the time of screening
Exclusion Criteria:
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Subjects who complain of a decrease in the sensation of the lower extremities or who is unable to feel the sensation of pain
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Subjects who have inflammation or trauma on the skin that directly touches the device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Presbyterian Medical Center | Jeonju | Korea, Republic of |
Sponsors and Collaborators
- Ceragem Clinical Inc.
Investigators
- Principal Investigator: Yong Soon Yoon, MD, Presbyterian medical center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-06-043