Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-12-22
2024-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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blood circulation treatment
Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT)
Blood circulation device
Blood circulation device of CGM MB-1701
Interventions
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Blood circulation device
Blood circulation device of CGM MB-1701
Eligibility Criteria
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Inclusion Criteria
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.
(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.)
3\. Subjects have 2 or more points of venous thromboembolism (hereinafter referred to as VTE) clinical prediction score (Two-level wells score) at the time of screening.
4\. Subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent
Exclusion Criteria
2. Subjects have inflammation or trauma on the skin that directly touches the device
19 Years
ALL
No
Sponsors
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Ceragem Clinical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joon-shik Yoon, MD
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Locations
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Presbyterian Medical Center
Jeonju, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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CGM-21-031
Identifier Type: -
Identifier Source: org_study_id
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