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OpenTrials
Completed

NCT Number: NCT05511064

CEFID-II (CEra Flow Improves DVT-II)

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).

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Presbyterian Medical Center, Jeonju, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult men and women over 19 years of age
  • 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.)

  • 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.
  • Subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent

Exclusion criteria

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

Treatment and study plan

Blood circulation device

Device

Blood circulation device of CGM MB-1701

Primary outcomes

  1. Peak Systolic Velocity (PSV) change

    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).

Secondary outcomes

  1. Peak Systolic Velocity (PSV) change

    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).

  2. Anteroposterior (AP) diameter

    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).

  3. Cross Sectional Area (CSA)

    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).

  4. Leg volume (3D scanner)

    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).

Sponsors and collaborators

Lead sponsor

Ceragem Clinical Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2022
Registry last updated
Feb 5, 2026

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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