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OpenTrials
Completed

NCT Number: NCT05469282

CEFID-I (CEra Flow Improves DVT-1)

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.

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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

About this study

The efficacy and safety evaluation are conducted before and after (or during) the application of the test device. The investigator shall apply an investigational device once when visiting a suitable subject for one day.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for all subjects; 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.

  • 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

Additional Inclusion Critetia for the DVT risk subjects;

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Blood circulation device

Device

Blood circulation device of CGM MB-1701 (Ceragem Master V6)

Primary outcomes

  1. Peak Systolic Velocity (PSV) change

    Time frame: While 2 consecutive application (36 minutes) per one subject

    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

Secondary outcomes

  1. Antero-posterior (AP) diameter

    Time frame: While 2 consecutive application (36 minutes) per one subject

    Evaluate the the maximum AP diameter change of the femoral vein when applied compared to before the device is applied using ultrasonic at Visit 1.

  2. Cross Sectional Area

    Time frame: While 2 consecutive application (36 minutes) per one subject

    Evaluate the maximum CSA area change of the femoral vein when applied compare to before the device is applied using ultrasonic at Visti 1.

Sponsors and collaborators

Lead sponsor

Ceragem Clinical Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2022
Registry last updated
Feb 9, 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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