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Safety and Feasibility of the ElastiMed's SACS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330925
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
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 .


Condition or disease Intervention/treatment Phase
Compression; Vein Device: ElastiMed's SACS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Safety and Feasibility of the ElastiMed's SACS - Smart Active Compression Stocking
Actual Study Start Date : January 24, 2018
Actual Primary Completion Date : December 3, 2018
Actual Study Completion Date : December 3, 2018

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330925


Locations
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Israel
Vascular Surgery Department, HILLEL YAFFE Medical Center,
Hadera, Israel, 38100
Sponsors and Collaborators
ElastiMed ltd
Investigators
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Study Chair: Vered Shuster, PhD ElastiMed ltd
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Responsible Party: ElastiMed ltd
ClinicalTrials.gov Identifier: NCT03330925    
Other Study ID Numbers: CP-001
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No