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Safety and Feasibility of the ElastiMed's SACS

NCT03330925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-06-06

No results posted yet for this study

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

Interventions

DEVICE

ElastiMed's SACS

A wearable medical device that improve circulation using smart materials

Sponsors & Collaborators

  • ElastiMed ltd

    lead INDUSTRY

Principal Investigators

  • Vered Shuster, PhD · ElastiMed ltd

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2018-12-03
Completion
2018-12-03

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03330925 on ClinicalTrials.gov