Blood circulation device
DeviceBlood circulation device of CGM MB-1701
NCT Number: NCT05511064
For Deep Vein Thrombosis (DVT) risk groups, the effect and safety of blood circulation improvement before and after application are evaluated using an investigational device (model name CGM MB-1701).
Looking for future studies?
Notify Me19 year and older
All sexes
Interventional
Not applicable
Presbyterian Medical Center, Jeonju, South Korea
The investigator applies the test device to the appropriate subjects for a total of 10 days (+1 days) at the institution and nursing hospital, and upon discharge for long-term follow-up investigation, the investigational device is applied at subjects' home according to the subject's consent for about 3 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(1) Subjects diagnosed by Doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea (2) D-dimer negative test result (Even if D-dimer is tested positive, it can be selected through additional tests at the discretion of investigator.)
Exclusion criteria
Blood circulation device of CGM MB-1701
Time frame: 10 days from the baseline
Compare the PSV change in the right lower extremity femoral vein at 10 days (V4) after application of the test device compared to the baseline (V2).
Time frame: 5 days from the baseline
Compare the PSV change in the right lower extremity femoral vein at 5 days (V3) after application of the test device compared to the baseline (V2).
Time frame: 5 days (V3) and 10 days (V4) from the baseline
Compare the maximum AP diameter change of the right lower femoral vein at 5 days (V3) and 10 days (V4) after the application of the test device compared to the baseline (V2).
Time frame: 5 days (V3) and 10 days (V4) from the baseline
Compare the maximum CSA change of the right lower femoral vein at 5 days (V3) and 10 days (V4) after the application of the test device compare to the baseline (V2).
Time frame: 5 days (V3) and 10 days (V4) from the baseline
Compare the amount of change in leg volume (3D scanner) (left and right) after application at 5 days (V3) and 10 days (V4) compared to the baseline (V2).
Ceragem Clinical Inc.
Industry
A Multiple Center, Clinical Trial to Evaluate the Efficacy and Safety of Blood Circulation Improvement Using an Investigational Device (Model Name CGM MB-1701) for the Risk Group of Deep Vein Thrombosis (DVT)
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.
Published trials that share one or more normalized conditions with this study.
NCT05469282
Blood Circulation Disorder, Cardiovascular Diseases
Jeonju, South Korea
View Trial DetailsNCT04396288
Blood Circulation Disorder, Bone Diseases
Paris, France
View Trial DetailsNCT04879875
Biosensing Techniques, Blood Circulation Disorder
Oslo, Norway
View Trial DetailsNCT05487820
Biosensing Techniques, Blood Circulation Disorder
Oslo, Norway
View Trial Details