CEFID-I (CEra Flow Improves DVT-1)

Deep Vein Thrombosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05469282
• Other study ID #: 2022-06-043
• Status: Completed
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2023
• Source: Ceragem Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

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 the D-dimer test is positive, the subject can be selected through the additional test at the discretion of investigator.)

3. 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;

1. 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:

1. Subjects who complain of a decrease in the sensation of the lower extremities or who is unable to feel the sensation of pain

2. Subjects who 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 (Ceragem Master V6)

Locations

Country	Name	City	State
Korea, Republic of	Presbyterian Medical Center	Jeonju

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	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	While 2 consecutive application (36 minutes) per one subject
Secondary	Antero-posterior (AP) diameter	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.	While 2 consecutive application (36 minutes) per one subject
Secondary	Cross Sectional Area	Evaluate the maximum CSA area change of the femoral vein when applied compare to before the device is applied using ultrasonic at Visti 1.	While 2 consecutive application (36 minutes) per one subject