Status:
COMPLETED
Safety and Feasibility of the ElastiMed's SACS
Lead Sponsor:
ElastiMed ltd
Conditions:
Compression; Vein
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03330925
Start Date
January 24 2018
End Date
December 3 2018
Last Update
June 6 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vascular Surgery Department, HILLEL YAFFE Medical Center,
Hadera, Israel, 38100