Safety and Feasibility of the ElastiMed's SACS

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

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 .

Study Overview

• Status: Completed
• Conditions: Compression; Vein
• Intervention / Treatment: Device: ElastiMed's SACS

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Vascular Surgery Department, HILLEL YAFFE Medical Center,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ElastiMed's SACS; Healthy Subjects which the Elastimed's SACS will be tried on	Device: ElastiMed's SACS; A wearable medical device that improve circulation using smart materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: ElastiMed ltd
• Investigators: Study Chair: Vered Shuster, PhD, ElastiMed ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2018
• Primary Completion (Actual): December 3, 2018
• Study Completion (Actual): December 3, 2018

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No