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

Primary Purpose

Edema Leg, Compression; Vein

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

ElastiMed's SACS 2.0

About this trial

This is an interventional treatment trial for Edema Leg

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sheba Medical Center at Tel HaShomerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temporarily or permanently wheelchair users which suffer from Venous Edema

Arm Description

Temporarily or permanently wheelchair users which suffer from Venous Edema

Outcomes

Primary Outcome Measures

Safety Endpoint

Accumulative rate of device related SAEs throughout the trial duration.

Efficacy Endpoint

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

Secondary Efficacy Endpoint

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

Full Information

NCT ID

NCT04837560

First Posted

April 6, 2021

Last Updated

April 6, 2021

Sponsor

ElastiMed ltd

1. Study Identification

Unique Protocol Identification Number

NCT04837560

Brief Title

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

Official Title

Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 2021 (Anticipated)

Primary Completion Date

August 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ElastiMed ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edema Leg, Compression; Vein

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Temporarily or permanently wheelchair users which suffer from Venous Edema

Arm Type

Experimental

Arm Description

Temporarily or permanently wheelchair users which suffer from Venous Edema

Intervention Type

Device

Intervention Name(s)

ElastiMed's SACS 2.0

Intervention Description

A wearable medical device that improve circulation using smart materials

Primary Outcome Measure Information:

Title

Safety Endpoint

Description

Accumulative rate of device related SAEs throughout the trial duration.

Time Frame

Device operation hours during 10 business days

Title

Efficacy Endpoint

Description

To demonstrate the efficacy by following the edema volume reduction after device application, in venous edema subjects, by measuring the calf circumference

Time Frame

Device operation hours during 10 business days

Secondary Outcome Measure Information:

Title

Secondary Efficacy Endpoint

Description

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

Time Frame

Device operation hours during 10 business days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vered Shuster, PhD

Phone

+972-54- 6819828

vered@elastimed.com

First Name & Middle Initial & Last Name or Official Title & Degree

Omer Zelka

Phone

+972-52- 6339131

omer@elastimed.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Israel Dudkiewicz, Prof.

Organizational Affiliation

Sheba Medical Center at Tel HaShomer

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sheba Medical Center at Tel HaShomer

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Israel Dudkiewicz, Prof

First Name & Middle Initial & Last Name & Degree

Doc

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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