Safety and Feasibility of the ElastiMed's SACS

Not Applicable

Completed

• Conditions: Compression; Vein
• Interventions: Device: ElastiMed's SACS

• Registration Number: NCT03330925
• Lead Sponsor: ElastiMed ltd

Brief 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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Study Start: 2018-01-24
• Status Verified: 2018-08
• Primary Completion: 2018-12-03
• Study Completion: 2018-12-03
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ElastiMed's SACS	ElastiMed's SACS	Healthy Subjects which the Elastimed's SACS will be tried on

Primary Outcome Measures

Name	Time	Method
Device feasibility measured by an increase in blood flow velocity	60 min	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
Safety measured by the number of subjects with serious adverse events	60 min	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

Trial Locations

Locations (1)

Vascular Surgery Department, HILLEL YAFFE Medical Center,; 🇮🇱 Hadera, Israel