CEFID-I (CEra Flow Improves DVT-1)

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis; Blood Circulation Disorder

• Registration Number: NCT05469282
• Lead Sponsor: Ceragem Clinical Inc.

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.

Study Timeline

• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-21
• Study Start: 2022-08-22
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Peak Systolic Velocity (PSV) change	While 2 consecutive application (36 minutes) per one subject	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

Name	Time	Method
Antero-posterior (AP) diameter	While 2 consecutive application (36 minutes) per one subject	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	While 2 consecutive application (36 minutes) per one subject	Evaluate the maximum CSA area change of the femoral vein when applied compare to before the device is applied using ultrasonic at Visti 1.

Trial Locations

Locations (1)

Presbyterian Medical Center; 🇰🇷 Jeonju, Korea, Republic of