Status:
UNKNOWN
Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking for the Treatment of Venous Edema
Lead Sponsor:
ElastiMed ltd
Conditions:
Edema Leg
Compression; Vein
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects must be between 18 to 80 years old
- Venous edema patients diagnosed by an indent in the skin following finger pressure.
- Venous edema in both calves
- Temporarily or permanently wheelchair users which are expected to remain so according to the investigator's discretion
- Subjects able to provide a written informed consent
- No existence of DVT according to leg deep vein Duplex test
- Exclusion Criteria as reported by patients: :
- Positive pregnancy test
- Breastfeeding woman
- moderate or severe Congestive heart failure
- Cellulitis of tissues of the lower limb.
- Infectious Dermatitis of the lower limb
- Acute or within 6 weeks of a deep vein thrombosis (DVT).
- Postphlebetic patients
- Known hypersensitivity to any component of the device
- Subjects unable to provide informed consent
- Active cancer at the root of the limb or in the adjacent quadrant
- Any limitation of renal function- according to the investigator's discretion
- Any limitation of liver function - according to the investigator's discretion
- Subject who cannot commit to a month of intensive standard therapy
- Wound or other skin condition that, according to the investigator's discretion, might be aggravated by the garment
- Currently participating in another clinical trial or have completed their participation in a clinical trial within 30 days of screening
- 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
- Cardiac or cerebral pacemaker or stimulator
- Patients after orthopedic / vascular injury in the lower extremities
Exclusion
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04837560
Start Date
April 1 2021
End Date
December 1 2021
Last Update
April 8 2021
Active Locations (1)
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1
Sheba Medical Center at Tel HaShomer
Ramat Gan, Israel, 52621