CEFID-II (CEra Flow Improves DVT-II)

Deep Vein Thrombosis Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05511064
• Other study ID #: CGM-21-031
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2023
• Source: Ceragem Inc.
• Contact: Hyungsun Kim
• Phone: 821045976672
• Email: hyungsun.kim[@]ceragem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Circulation Disorder
• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• Blood circulation device
Blood circulation device of CGM MB-1701

Locations

Country	Name	City	State
Korea, Republic of	Presbyterian Medical Center	Jeonju
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ceragem Clinical Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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