Presbyterian Medical Center
Jeonju, South Korea
NCT Number: NCT05469282
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.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Jeonju, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Additional Inclusion Critetia for the DVT risk subjects;
Exclusion criteria
Blood circulation device of CGM MB-1701 (Ceragem Master V6)
Time frame: 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
Time frame: 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.
Time frame: 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.
Ceragem Clinical Inc.
Industry
A Single Center Clinical Trial to Evaluate the Efficacy and Safety of Blood Circulation Improvement Using an Investigational Medical Device (Model Name CGM MB-1701) for the Risk Group of Deep Vein Thrombosis (DVT) and the Ordinary Person
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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