Edema LegPhase 1NCT04837560
Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking for the Treatment of Venous Edema
A Phase 1 study testing ElastiMed's SACS 2.0 in people with Edema Leg and Compression; Vein, run by ElastiMed ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Edema Leg, Compression; Vein
- What is being tested?
- ElastiMed's SACS 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2021to Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center at Tel HaShomer
Ramat Gan, 52621
Israel Dudkiewicz, Prof
Doc
About this study
Official title: Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking
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
- Being tested
- ElastiMed's SACS 2.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElastiMed's SACS 2.0Device
A wearable medical device that improve circulation using smart materials
| Study group | Role | What they receive |
|---|---|---|
| Temporarily or permanently wheelchair users which suffer from Venous Edema | Experimental | Temporarily or permanently wheelchair users which suffer from Venous Edema Receives: Device: ElastiMed's SACS 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint
Accumulative rate of device related SAEs throughout the trial duration.
Measured: 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
Measured: Device operation hours during 10 business days
Secondary outcomes (1)
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
Measured: Device operation hours during 10 business days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edema LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ElastiMed ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Israel Dudkiewicz, Prof., Principal investigator, Sheba Medical Center at Tel HaShomer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837560
- Sponsor's protocol ID
- CP-002
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking
- ClinicalTrials.gov ID
- NCT04837560
- Acronym / sponsor ID
- CP-002
- Conditions
- Edema Leg, Compression; Vein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ElastiMed ltdIndustry (pharma, biotech, devices)
- Study start
- Apr 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporarily or permanently wheelchair users which suffer from Venous Edema | Experimental | Device: ElastiMed's SACS 2.0Temporarily or permanently wheelchair users which suffer from Venous Edema |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- Positive pregnancy test
- Breastfeeding woman
- moderate or severe Congestive heart failure
- Cellulitis of tissues of the lower limb.
- Infectious Dermatitis of the lower limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElastiMed's SACS 2.0A wearable medical device that improve circulation using smart materials | Device | Temporarily or permanently wheelchair users which suffer from Venous Edema |
Primary outcome
Safety Endpoint
Time frame: Device operation hours during 10 business days
Accumulative rate of device related SAEs throughout the trial duration.
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
1 secondary outcome
Secondary Efficacy Endpoint
Time frame: Device operation hours during 10 business days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Israel Dudkiewicz, Prof. principal investigator
Sheba Medical Center at Tel HaShomer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ElastiMed's SACS 2.0 in people with Edema Leg and Compression; Vein, run by ElastiMed ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vered Shuster, PhD (+972-54- 6819828, vered@elastimed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint (time frame: Device operation hours during 10 business days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.