CEFID-II (CEra Flow Improves DVT-II)
Primary Purpose
Blood Circulation Disorder, Deep Vein Thrombosis
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Blood circulation device
Sponsored by
About this trial
This is an interventional prevention trial for Blood Circulation Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
(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
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:
- 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
Sites / Locations
- Presbyterian Medical CenterRecruiting
- Korea University Guro Hospital
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
blood circulation treatment
Arm Description
Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05511064
Brief Title
CEFID-II (CEra Flow Improves DVT-II)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
September 28, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ceragem Clinical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Circulation Disorder, Deep Vein Thrombosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
blood circulation treatment
Arm Type
Experimental
Arm Description
Blood circulation treatment for the risk group for Deep Vein Thrombosis (DVT)
Intervention Type
Device
Intervention Name(s)
Blood circulation device
Intervention Description
Blood circulation device of CGM MB-1701
Primary Outcome Measure Information:
Title
Peak Systolic Velocity (PSV) change
Description
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).
Time Frame
10 days from the baseline
Secondary Outcome Measure Information:
Title
Peak Systolic Velocity (PSV) change
Description
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).
Time Frame
5 days from the baseline
Title
Anteroposterior (AP) diameter
Description
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).
Time Frame
5 days (V3) and 10 days (V4) from the baseline
Title
Cross Sectional Area (CSA)
Description
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).
Time Frame
5 days (V3) and 10 days (V4) from the baseline
Title
Leg volume (3D scanner)
Description
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).
Time Frame
5 days (V3) and 10 days (V4) from the baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
(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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyungsun Kim
Phone
821045976672
Email
hyungsun.kim@ceragem.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sungjin Kim
Email
sungjin.kim@ceragem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-shik Yoon, MD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Presbyterian Medical Center
City
Jeonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Soon Yoon, MD
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon Shik Yoon, MD
Facility Name
Seoul National University Bundang Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaewon Beom, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CEFID-II (CEra Flow Improves DVT-II)
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