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CEFID-I (CEra Flow Improves DVT-1)

Primary Purpose

Blood Circulation Disorder, Deep Vein Thrombosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Blood circulation device
Sponsored by
Ceragem Clinical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Circulation Disorder

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

Sites / Locations

  • Presbyterian Medical Center

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) and the ordinary person

Outcomes

Primary Outcome Measures

Peak Systolic Velocity (PSV) change
Evaluate the maximum blood flow rate (PSV) change in the femoral vein when applied compared to before application of the device using ultrasonic at Visit 1

Secondary Outcome Measures

Antero-posterior (AP) diameter
Evaluate the the maximum AP diameter change of the femoral vein when applied compared to before the device is applied using ultrasonic at Visit 1.
Cross Sectional Area
Evaluate the maximum CSA area change of the femoral vein when applied compare to before the device is applied using ultrasonic at Visti 1.

Full Information

First Posted
July 19, 2022
Last Updated
January 5, 2023
Sponsor
Ceragem Clinical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05469282
Brief Title
CEFID-I (CEra Flow Improves DVT-1)
Official Title
A Single Center Clinical Trial to Evaluate the Efficacy and Safety of Blood Circulation Improvement Using an Investigational Medical Device (Model Name CGM MB-1701) for the Risk Group of Deep Vein Thrombosis (DVT) and the Ordinary Person
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

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
59 (Actual)

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) and the ordinary person
Intervention Type
Device
Intervention Name(s)
Blood circulation device
Intervention Description
Blood circulation device of CGM MB-1701 (Ceragem Master V6)
Primary Outcome Measure Information:
Title
Peak Systolic Velocity (PSV) change
Description
Evaluate the maximum blood flow rate (PSV) change in the femoral vein when applied compared to before application of the device using ultrasonic at Visit 1
Time Frame
While 2 consecutive application (36 minutes) per one subject
Secondary Outcome Measure Information:
Title
Antero-posterior (AP) diameter
Description
Evaluate the the maximum AP diameter change of the femoral vein when applied compared to before the device is applied using ultrasonic at Visit 1.
Time Frame
While 2 consecutive application (36 minutes) per one subject
Title
Cross Sectional Area
Description
Evaluate the maximum CSA area change of the femoral vein when applied compare to before the device is applied using ultrasonic at Visti 1.
Time Frame
While 2 consecutive application (36 minutes) per one subject

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. Subjects diagnosed by Doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea 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: Subjects who complain of a decrease in the sensation of the lower extremities or who is unable to feel the sensation of pain Subjects who have inflammation or trauma on the skin that directly touches the device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Soon Yoon, MD
Organizational Affiliation
Presbyterian medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Presbyterian Medical Center
City
Jeonju
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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CEFID-I (CEra Flow Improves DVT-1)

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