Blood Circulation DisorderNCT05511064
CEFID-II (CEra Flow Improves DVT-II)
A study testing Blood circulation device in people with Blood Circulation Disorder and Deep Vein Thrombosis, run by Ceragem Clinical Inc. at 3 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Blood Circulation Disorder, Deep Vein Thrombosis
- What is being tested?
- Blood circulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 22 Dec 2022to 28 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women over 19 years of age
- 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.
- 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
Who cannot join
- Subjects complain of a decrease in the sensation of the lower extremities or is unable to feel the sensation of pain
- Subjects have inflammation or trauma on the skin that directly touches the device
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Presbyterian Medical Center
Jeonju
Korea University Guro Hospital
Seoul
Seoul National University Bundang Hospital
Seoul
About this study
Official title: A Multiple Center, Clinical Trial to Evaluate the Efficacy and Safety of Blood Circulation Improvement Using an Investigational Device (Model Name CGM MB-1701) for the Risk Group of Deep Vein Thrombosis (DVT)
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).
Read the 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.
- Conditions
- Blood Circulation Disorder, Deep Vein Thrombosis
- Being tested
- Blood circulation device
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood circulation deviceDevice
Blood circulation device of CGM MB-1701
| Study group | Role | What they receive |
|---|---|---|
| blood circulation treatment | Experimental | Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT) Receives: Device: Blood circulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Systolic Velocity (PSV) change
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).
Measured: 10 days from the baseline
Secondary outcomes (4)
Peak Systolic Velocity (PSV) change
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).
Measured: 5 days from the baseline
Anteroposterior (AP) diameter
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).
Measured: 5 days (V3) and 10 days (V4) from the baseline
Cross Sectional Area (CSA)
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).
Measured: 5 days (V3) and 10 days (V4) from the baseline
Leg volume (3D scanner)
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).
Measured: 5 days (V3) and 10 days (V4) from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start22 Dec 2022
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Circulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceragem Clinical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joon-shik Yoon, MD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511064
- Sponsor's protocol ID
- CGM-21-031
- Status last verified
- Feb 2026
- First submitted
- 19 Aug 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Center, Clinical Trial to Evaluate the Efficacy and Safety of Blood Circulation Improvement Using an Investigational Device (Model Name CGM MB-1701) for the Risk Group of Deep Vein Thrombosis (DVT)
- ClinicalTrials.gov ID
- NCT05511064
- Acronym / sponsor ID
- CGM-21-031
- Conditions
- Blood Circulation Disorder, Deep Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ceragem Clinical Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood circulation treatment | Experimental | Device: Blood circulation deviceBlood circulation treatment for the risk group for Deep Vein Thrombosis (DVT) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult men and women over 19 years of age
- 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.
- 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
Key exclusion criteria (2 listed)
- Subjects complain of a decrease in the sensation of the lower extremities or is unable to feel the sensation of pain
- Subjects have inflammation or trauma on the skin that directly touches the device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood circulation deviceBlood circulation device of CGM MB-1701 | Device | blood circulation treatment |
Primary outcome
Peak Systolic Velocity (PSV) change
Time frame: 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).
4 secondary outcomes
Peak Systolic Velocity (PSV) change
Time frame: 5 days from the baseline
Anteroposterior (AP) diameter
Time frame: 5 days (V3) and 10 days (V4) from the baseline
Cross Sectional Area (CSA)
Time frame: 5 days (V3) and 10 days (V4) from the baseline
Leg volume (3D scanner)
Time frame: 5 days (V3) and 10 days (V4) from the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joon-shik Yoon, MD principal investigator
Korea University Guro Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood circulation device in people with Blood Circulation Disorder and Deep Vein Thrombosis, run by Ceragem Clinical Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Systolic Velocity (PSV) change (time frame: 10 days from the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.