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)

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).

Study Overview

• Status: Recruiting
• Conditions: Deep Vein Thrombosis; Blood Circulation Disorder
• Intervention / Treatment: Device: Blood circulation device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sungjin Kim; Email: sungjin.kim@ceragem.com
• Study Contact Backup: Name: Hyungsun Kim; Phone Number: 821045976672; Email: hyungsun.kim@ceragem.com

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Recruiting
    • Presbyterian Medical Center
    • Contact: Yong soon Yoon, MD
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Korea University Guro Hospital
    • Contact: Joon Shik Yoon, MD
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Seoul National University Bundang Hospital
    • Contact: Jaewon Beom, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: blood circulation treatment; Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT)	Device: Blood circulation device; Blood circulation device of CGM MB-1701

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Systolic Velocity (PSV) change	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).	10 days from the baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Systolic Velocity (PSV) change	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).	5 days from the baseline
Anteroposterior (AP) diameter	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).	5 days (V3) and 10 days (V4) from the baseline
Cross Sectional Area (CSA)	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).	5 days (V3) and 10 days (V4) from the baseline
Leg volume (3D scanner)	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).	5 days (V3) and 10 days (V4) from the baseline

Collaborators and Investigators

• Sponsor: Ceragem Clinical Inc.
• Investigators: Principal Investigator: Joon-shik Yoon, MD, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Anticipated): September 28, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: CGM-21-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No