CEFID-I (CEra Flow Improves DVT-1)

Ceragem Clinical

Status: Completed

Conditions: Deep Vein Thrombosis; Blood Circulation Disorder

Treatments: Device: Blood circulation device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05469282

2022-06-043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

blood circulation treatment

Experimental group

Description:

Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT) and the ordinary person

Treatment:

Device: Blood circulation device