Safety and Feasibility of the ElastiMed's SACS

Compression; Vein Clinical Trial

Official title:

Safety and Feasibility of the ElastiMed's SACS - Smart Active Compression Stocking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330925
• Other study ID #: CP-001
• Status: Completed
• Phase: N/A
• Start date: January 24, 2018
• Est. completion date: December 3, 2018

Study information

• Verified date: August 2018
• Source: ElastiMed ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to demonstrate the safety and the feasibility of this device, and its ability to increase venous blood flow

Primary safety Endpoint:

To demonstrate the safety of the device- no serious adverse effect

Primary feasibility Endpoint:

Increase the blood flow velocity

The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein and the femoral vein.

The volunteers will rest at controlled environment room . Measurements will be performed after 30 min of rest without the device on the leg (baseline) and after 30 min of device activity .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 3, 2018
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Adults 18<x<70 Years

2. Written informed consent has been sign by subject

3. With two healthy limbs - Normal blood flow according to leg deep vein Duplex test

Exclusion Criteria:

1. Positive pregnancy test

2. Breastfeeding woman

3. BMI 18.5 > X or X>25

4. Suffering from edema

5. Atrial fibrillation

6. DVT

7. Ulcers or cellulitis in regions covered by the compression device

8. Active phlebitis

9. Muscular disorders, or compartment syndrome

10. Heavy smoker >10 cigarettes a day

11. Subjects with altered mental status/inability to provide informed consent

12. Hematological disorders

Related Conditions & MeSH terms

• Compression; Vein

Intervention

Device:
• ElastiMed's SACS
A wearable medical device that improve circulation using smart materials

Locations

Country	Name	City	State
Israel	Vascular Surgery Department, HILLEL YAFFE Medical Center,	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
ElastiMed ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by the number of subjects with serious adverse events	The safety analysis set will contain of all subjects who were enrolled into the study.; Individual listings of adverse events including type of device, adverse events (reported term), seriousness, duration, relationship to the study device, severity and the adverse events outcome will be provided	60 min
Primary	Device feasibility measured by an increase in blood flow velocity	The primary feasibility assessment will be based on the ability of the device to increase the blood flow velocity at the popliteal vein. The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein. Two Measurements will be performed, the first will be after 30 minutes of rest without the device on the leg (baseline) (T0) and the second will be after 30 min of device activity	60 min