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Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking for the Treatment of Venous Edema

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04837560
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
ElastiMed ltd

Study Description
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Brief Summary:

Device Efficacy:

The primary efficacy assessment will be defined as successful if the edema volume will be reduced over time after using the SACS 2.0 device.

Treatment and edema evaluation will be performed in comparison to a standard compression bandage. The treatment will be performed for several hours during the subject's daily rest time.

The Measurements will be performed daily before treatment initiation and without the device on the leg (baseline) (T0); and after four hours of device operation.

The edema volume will be measured by a calf circumference measurement.


Condition or disease Intervention/treatment Phase
Edema Leg Compression; Vein Device: ElastiMed's SACS 2.0 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Temporarily or permanently wheelchair users which suffer from Venous Edema
Temporarily or permanently wheelchair users which suffer from Venous Edema
 Device: ElastiMed's SACS 2.0
A wearable medical device that improve circulation using smart materials


Outcome Measures
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Primary Outcome Measures :
  1. Safety Endpoint [ Time Frame: Device operation hours during 10 business days ]
    Accumulative rate of device related SAEs throughout the trial duration.

  2. Efficacy Endpoint [ Time Frame: Device operation hours during 10 business days ]
    To demonstrate the efficacy by following the edema volume reduction after device application, in venous edema subjects, by measuring the calf circumference


Secondary Outcome Measures :
  1. Secondary Efficacy Endpoint [ Time Frame: Device operation hours during 10 business days ]
    To demonstrate the efficacy by changing the edema volume after using the SACS 2.0 device at least as much as after using a compression bandage


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be between 18 to 80 years old
  2. Venous edema patients diagnosed by an indent in the skin following finger pressure.
  3. Venous edema in both calves
  4. Temporarily or permanently wheelchair users which are expected to remain so according to the investigator's discretion
  5. Subjects able to provide a written informed consent
  6. No existence of DVT according to leg deep vein Duplex test

Exclusion Criteria as reported by patients: :

  1. Positive pregnancy test
  2. Breastfeeding woman
  3. moderate or severe Congestive heart failure
  4. Cellulitis of tissues of the lower limb.
  5. Infectious Dermatitis of the lower limb
  6. Acute or within 6 weeks of a deep vein thrombosis (DVT).
  7. Postphlebetic patients
  8. Known hypersensitivity to any component of the device
  9. Subjects unable to provide informed consent
  10. Active cancer at the root of the limb or in the adjacent quadrant
  11. Any limitation of renal function- according to the investigator's discretion
  12. Any limitation of liver function - according to the investigator's discretion
  13. Subject who cannot commit to a month of intensive standard therapy
  14. Wound or other skin condition that, according to the investigator's discretion, might be aggravated by the garment
  15. Currently participating in another clinical trial or have completed their participation in a clinical trial within 30 days of screening
  16. Other physical and/or mental conditions that, according to the investigator's discretion, prevent the subject from participating in the trial and completing its assessments
  17. Cardiac or cerebral pacemaker or stimulator
  18. Patients after orthopedic / vascular injury in the lower extremities
Contacts and Locations
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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): NCT04837560


Contacts
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Contact: Vered Shuster, PhD +972-54- 6819828 vered@elastimed.com
Contact: Omer Zelka +972-52- 6339131 omer@elastimed.com

Locations
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Israel
Sheba Medical Center at Tel HaShomer Recruiting
Ramat Gan, Israel, 52621
Contact: Israel Dudkiewicz, Prof         
Contact: Doc         
Sponsors and Collaborators
ElastiMed ltd
Investigators
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Principal Investigator: Israel Dudkiewicz, Prof. Sheba Medical Center at Tel HaShomer
More Information
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Responsible Party: ElastiMed ltd
ClinicalTrials.gov Identifier: NCT04837560    
Other Study ID Numbers: CP-002
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
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
Additional relevant MeSH terms:
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Edema