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OpenTrials
Completed

NCT Number: NCT03330925

Safety and Feasibility of the ElastiMed's SACS

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 .

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Key information

Conditions

Compression; Vein

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vascular Surgery Department, HILLEL YAFFE Medical Center,

Hadera, 38100, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 18<x<70 Years
  • Written informed consent has been sign by subject
  • With two healthy limbs - Normal blood flow according to leg deep vein Duplex test

Exclusion criteria

  • Positive pregnancy test
  • Breastfeeding woman
  • BMI 18.5 > X or X>25
  • Suffering from edema
  • Atrial fibrillation
  • DVT
  • Ulcers or cellulitis in regions covered by the compression device
  • Active phlebitis
  • Muscular disorders, or compartment syndrome
  • Heavy smoker >10 cigarettes a day
  • Subjects with altered mental status/inability to provide informed consent
  • Hematological disorders

Treatment and study plan

ElastiMed's SACS

Device

A wearable medical device that improve circulation using smart materials

Primary outcomes

  1. Safety measured by the number of subjects with serious adverse events

    Time frame: 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

  2. Device feasibility measured by an increase in blood flow velocity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ElastiMed ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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