CEFID-II (CEra Flow Improves DVT-II)

Not Applicable

Recruiting

• Conditions: Deep Vein Thrombosis; Blood Circulation Disorder
• Interventions: Device: Blood circulation device

• Registration Number: NCT05511064
• Lead Sponsor: Ceragem Clinical Inc.

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.

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2022-12-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01
• Primary Completion: 2023-09-28
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
blood circulation treatment	Blood circulation device	Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (3)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of

Presbyterian Medical Center; 🇰🇷 Jeonju, Korea, Republic of