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

NCT04837560 | Unknown Phase 1

• 1 other identifier: CP-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Edema Leg; Compression; Vein

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint

  Accumulative rate of device related SAEs throughout the trial duration.

  Device operation hours during 10 business days

• Efficacy Endpoint

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

  Device operation hours during 10 business days

Secondary Outcomes (1)

• Secondary Efficacy Endpoint

  Device operation hours during 10 business days

Study Arms (1)

Temporarily or permanently wheelchair users which suffer from Venous Edema

EXPERIMENTAL

Temporarily or permanently wheelchair users which suffer from Venous Edema

Device: ElastiMed's SACS 2.0

Interventions

ElastiMed's SACS 2.0 DEVICE

A wearable medical device that improve circulation using smart materials

Temporarily or permanently wheelchair users which suffer from Venous Edema

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ElastiMed ltd: lead

Study Sites (1)

Sheba Medical Center at Tel HaShomer

Ramat Gan, 52621, Israel

RECRUITING

Study Officials

• Israel Dudkiewicz, Prof.

  Sheba Medical Center at Tel HaShomer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vered Shuster, PhD

CONTACT

+972-54- 6819828; vered@elastimed.com

Omer Zelka

CONTACT

+972-52- 6339131; omer@elastimed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)