CEFID-I (CEra Flow Improves DVT-1)

NCT ID: NCT05469282

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2022-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Blood Circulation Disorder Deep Vein Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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blood circulation treatment

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

Group Type EXPERIMENTAL

Blood circulation device

Intervention Type DEVICE

Blood circulation device of CGM MB-1701 (Ceragem Master V6)

Interventions

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Blood circulation device

Blood circulation device of CGM MB-1701 (Ceragem Master V6)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ceragem Clinical Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yong Soon Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

Presbyterian medical center

Locations

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Presbyterian Medical Center

Jeonju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2022-06-043

Identifier Type: -

Identifier Source: org_study_id

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