Safety and Feasibility of the ElastiMed's SACS

NCT03330925 | Completed

• 1 other identifier: CP-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 .

Conditions

Compression; Vein

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

ElastiMed's SACS

EXPERIMENTAL

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

Device: ElastiMed's SACS

Interventions

ElastiMed's SACS DEVICE

A wearable medical device that improve circulation using smart materials

ElastiMed's SACS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ElastiMed ltd: lead

Study Sites (1)

Vascular Surgery Department, HILLEL YAFFE Medical Center,

Hadera, 38100, Israel

Location

Study Officials

• Vered Shuster, PhD

  ElastiMed ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 6, 2017
• Study Start: January 24, 2018
• Primary Completion: December 3, 2018
• Study Completion: December 3, 2018
• Last Updated: June 6, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)