CEFID-II (CEra Flow Improves DVT-II)

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)

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05511064

Enrollment

Registered

2022-08-22

Start date

2022-12-22

Completion date

2024-10-28

Last updated

2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Circulation Disorder, Deep Vein Thrombosis

Brief summary

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).

Detailed description

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.

Interventions

DEVICEBlood circulation device

Blood circulation device of CGM MB-1701

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

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. (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

1. Subjects complain of a decrease in the sensation of the lower extremities or is unable to feel the sensation of pain 2. Subjects have inflammation or trauma on the skin that directly touches the device

Design outcomes

Primary

Measure	Time frame	Description
Peak Systolic Velocity (PSV) change	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).

Secondary

Measure	Time frame	Description
Peak Systolic Velocity (PSV) change	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).
Anteroposterior (AP) diameter	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).
Cross Sectional Area (CSA)	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).
Leg volume (3D scanner)	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).

Countries

South Korea

Contacts

PRINCIPAL_INVESTIGATORJoon-shik Yoon, MD

Korea University Guro Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026