Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2018-01-24
2018-12-03
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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ElastiMed's SACS
Healthy Subjects which the Elastimed's SACS will be tried on
ElastiMed's SACS
A wearable medical device that improve circulation using smart materials
Interventions
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ElastiMed's SACS
A wearable medical device that improve circulation using smart materials
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
Yes
Sponsors
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ElastiMed ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Vered Shuster, PhD
Role: STUDY_CHAIR
ElastiMed ltd
Locations
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Vascular Surgery Department, HILLEL YAFFE Medical Center,
Hadera, , Israel
Countries
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Other Identifiers
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CP-001
Identifier Type: -
Identifier Source: org_study_id
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