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Cera-Flow: Blood Circulation Long Term Study

Sponsor
Ceragem Clinical Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05511064
Collaborator
(none)
60
Enrollment
1
Arm
7.1
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Blood circulation device
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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)
Anticipated Study Start Date :
Oct 25, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: blood circulation treatment

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

Device: Blood circulation device
Blood circulation device of CGM MB-1701

Outcome Measures

Primary Outcome Measures

  1. Peak Systolic Velocity (PSV) change [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).

Secondary Outcome Measures

  1. Peak Systolic Velocity (PSV) change [5 days from the baseline]

    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).

  2. Anteroposterior (AP) diameter [5 days (V3) and 10 days (V4) from the baseline]

    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).

  3. Cross Sectional Area (CSA) [5 days (V3) and 10 days (V4) from the baseline]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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.

  2. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ceragem Clinical Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ceragem Clinical Inc.
ClinicalTrials.gov Identifier:
NCT05511064
Other Study ID Numbers:
  • CGM-21-031
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis

Study Results

No Results Posted as of Aug 22, 2022