CEFID-I (CEra Flow Improves DVT-1)
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
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 21, 2022
CompletedStudy Start
First participant enrolled
August 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedFebruary 9, 2026
February 1, 2026
4 months
July 19, 2022
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Peak Systolic Velocity (PSV) change
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
While 2 consecutive application (36 minutes) per one subject
Secondary Outcomes (2)
Antero-posterior (AP) diameter
While 2 consecutive application (36 minutes) per one subject
Cross Sectional Area
While 2 consecutive application (36 minutes) per one subject
Study Arms (1)
blood circulation treatment
EXPERIMENTALBlood circulation treatment for the risk group for Deep Vein Thrombosis (DVT) and the ordinary person
Interventions
Blood circulation device of CGM MB-1701 (Ceragem Master V6)
Eligibility Criteria
You may qualify if:
- Subjects diagnosed by Doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea
- D-dimer negative test result (Even if the D-dimer test is positive, the subject can be selected through the additional test at the discretion of investigator.)
- \. Subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent
- \. 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
You may not qualify if:
- Subjects who complain of a decrease in the sensation of the lower extremities or who is unable to feel the sensation of pain
- Subjects who have inflammation or trauma on the skin that directly touches the device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Presbyterian Medical Center
Jeonju, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Soon Yoon, MD
Presbyterian medical center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2022
First Posted
July 21, 2022
Study Start
August 22, 2022
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
February 9, 2026
Record last verified: 2026-02