Safety and Feasibility of the ElastiMed's SACS

ElastiMed

Status: Completed

Conditions: Compression; Vein

Treatments: Device: ElastiMed's SACS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03330925

CP-001

Details and patient eligibility

About

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 .

Enrollment: 11 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

ElastiMed's SACS

Experimental group

Description:

Healthy Subjects which the Elastimed's SACS will be tried on

Treatment:

Device: ElastiMed's SACS