CEFID-II (CEra Flow Improves DVT-II)

NCT ID: NCT05511064

Last Updated: 2026-02-05

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-22

Study Completion Date

2024-10-28

Brief Summary

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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

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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.

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)

Group Type EXPERIMENTAL

Blood circulation device

Intervention Type DEVICE

Blood circulation device of CGM MB-1701

Interventions

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Blood circulation device

Blood circulation device of CGM MB-1701

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Joon-shik Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Presbyterian Medical Center

Jeonju, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Seoul National University Bundang Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CGM-21-031

Identifier Type: -

Identifier Source: org_study_id

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