Compression; VeinNCT03330925
Safety and Feasibility of the ElastiMed's SACS
A study testing ElastiMed's SACS in people with Compression; Vein, run by ElastiMed ltd at 1 site in Israel.
Trial summary
The main objective of this study is to demonstrate the safety and the feasibility of this device, and its ability to increase venous blood flow Primary safety Endpoint: To demonstrate the safety of the device- no serious adverse effect Primary feasibility Endpoint: Increase the blood flow velocity The blood flow will… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Compression; Vein
- What is being tested?
- ElastiMed's SACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Jan 2018to 3 Dec 2018
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18<x<70 Years
- Written informed consent has been sign by subject
- With two healthy limbs - Normal blood flow according to leg deep vein Duplex test
Who cannot join
- Positive pregnancy test
- Breastfeeding woman
- BMI 18.5 > X or X>25
- Suffering from edema
- Atrial fibrillation
- DVT
Show all 12Show fewer
- Ulcers or cellulitis in regions covered by the compression device
- Active phlebitis
- Muscular disorders, or compartment syndrome
- Heavy smoker >10 cigarettes a day
- Subjects with altered mental status/inability to provide informed consent
- Hematological disorders
Trial locations and contacts
1 site in 1 country.
Israel1 site
Vascular Surgery Department, HILLEL YAFFE Medical Center,
Hadera, 38100
About this study
Official title: Safety and Feasibility of the ElastiMed's SACS - Smart Active Compression Stocking
The main objective of this study is to demonstrate the safety and the feasibility of this device, and its ability to increase venous blood flow
Primary safety Endpoint:
To demonstrate the safety of the device- no serious adverse effect
Primary feasibility Endpoint:
Increase the blood flow velocity
The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein and the femoral vein.
The volunteers will rest at controlled environment room . Measurements will be performed after 30 min of rest without the device on the leg (baseline) and after 30 min of device activity .
- Conditions
- Compression; Vein
- Being tested
- ElastiMed's SACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElastiMed's SACSDevice
A wearable medical device that improve circulation using smart materials
| Study group | Role | What they receive |
|---|---|---|
| ElastiMed's SACS | Experimental | Healthy Subjects which the Elastimed's SACS will be tried on Receives: Device: ElastiMed's SACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by the number of subjects with serious adverse events
The safety analysis set will contain of all subjects who were enrolled into the study.
Individual listings of adverse events including type of device, adverse events (reported term), seriousness, duration, relationship to the study device, severity and the adverse events outcome will be provided
Measured: 60 min
Device feasibility measured by an increase in blood flow velocity
The primary feasibility assessment will be based on the ability of the device to increase the blood flow velocity at the popliteal vein. The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein. Two Measurements will be performed, the first will be after 30 minutes of rest without the device on the leg (baseline) (T0) and the second will be after 30 min of device activity
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start24 Jan 2018
- Primary completion3 Dec 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compression; VeinStudies 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElastiMed ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vered Shuster, PhD, Study chair, ElastiMed ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330925
- Sponsor's protocol ID
- CP-001
- Status last verified
- Aug 2018
- First submitted
- 25 Oct 2017
- Last updated
- 6 Jun 2019
- 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 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of the ElastiMed's SACS - Smart Active Compression Stocking
- ClinicalTrials.gov ID
- NCT03330925
- Acronym / sponsor ID
- CP-001
- Conditions
- Compression; Vein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- ElastiMed ltdIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 6 Nov 2017 (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.
The main objective of this study is to demonstrate the safety and the feasibility of this device, and its ability to increase venous blood flow
Primary safety Endpoint:
To demonstrate the safety of the device- no serious adverse effect
Primary feasibility Endpoint:
Increase the blood flow velocity
The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein and the femoral vein.
The volunteers will rest at controlled environment room . Measurements will be performed after 30 min of rest without the device on the leg (baseline) and after 30 min of device activity .
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ElastiMed's SACS | Experimental | Device: ElastiMed's SACSHealthy Subjects which the Elastimed's SACS will be tried on |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18<x<70 Years
- Written informed consent has been sign by subject
- With two healthy limbs - Normal blood flow according to leg deep vein Duplex test
Key exclusion criteria (12 listed)
- Positive pregnancy test
- Breastfeeding woman
- BMI 18.5 > X or X>25
- Suffering from edema
- Atrial fibrillation
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 SACSA wearable medical device that improve circulation using smart materials | Device | ElastiMed's SACS |
Primary outcome
Safety measured by the number of subjects with serious adverse events
Time frame: 60 min
The safety analysis set will contain of all subjects who were enrolled into the study. Individual listings of adverse events including type of device, adverse events (reported term), seriousness, duration, relationship to the study device, severity and the adverse events outcome will be provided
Device feasibility measured by an increase in blood flow velocity
Time frame: 60 min
The primary feasibility assessment will be based on the ability of the device to increase the blood flow velocity at the popliteal vein. The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein. Two Measurements will be performed, the first will be after 30 minutes of rest without the device on the leg (baseline) (T0) and the second will be after 30 min of device activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Compression; Vein
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Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI
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Prospective Stratified Randomized Four-Group Study of Cabin Class and Graduated Compression Stockings on Popliteal Vein Dilation After Long-Haul Air Travel After Aesthetic Surgery
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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.
Vered Shuster, PhD study chair
ElastiMed ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ElastiMed's SACS in people with 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 6 Jun 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by the number of subjects with serious adverse events (time frame: 60 min). 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 6 Jun 2019.