HemodynamicsNCT05945186
Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System
A study testing Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves) in people with Hemodynamics, run by Cardinal Health at 1 site in United States.
Trial summary
This study is being conducted to evaluate the hemodynamic performance (i.e. flow of blood) in the legs using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamics
- What is being tested?
- Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2023to Nov 2023
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be ≥18 years and ≤ 89 years of age.
- Subject must be able to speak and read English.
- Subject must have both legs fully intact (cannot be an amputee) with normal function.
- Subject must be able to commit to the full study duration (approximately 1-2 hours of uninterrupted time).
- Subject legs must fit into the provided knee length compression sleeves (<32").
- Subject must give written informed consent.
Who cannot join
- Subject is currently pregnant or breastfeeding.
- Subject has a positive COVID history within the previous 6 months.
- Subject presents with
- - local leg condition with which the sleeves would interfere such as dermatitis, vein ligation (immediate post-operative), gangrene, recent skin graft, or any other open wound
- - arteriosclerosis or other ischemic vascular diseases as indicated by absence of pedal pulses and/or history of intermittent claudication with positive pain response
- - edema of legs or pulmonary edema from congestive heart failure
Show all 13Show fewer
- - deformity of the leg
- - current Deep Vein Thrombosis as identified during baseline clinical screening
- - recent or old Deep Vein Thrombosis as identified during baseline clinical screening
- - reflux in the superficial or deep veins
- - history of DVT/PE
- - known May-Thurner Syndrome
- Subject who, in the opinion of the investigator, is not an appropriate candidate for the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jobst Vascular Institute
Toledo, Ohio, 43606
Study Coordinator
About this study
Official title: Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System With Cardinal Health Element Compression Sleeves
This study is being conducted to evaluate the hemodynamic performance (i.e. flow of blood) in the legs using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves.
Read the detailed description
This study is being conducted to evaluate hemodynamic performance using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves. The study is intended to confirm the system's ability to increase venous blood flow over baseline as measured by blood velocity, time average mean velocity and total volume flow, in both the femoral and popliteal veins.
- Conditions
- Hemodynamics
- Being tested
- Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)
- Keywords
- Hemodynamics, Blood Flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)Device
External intermittent pneumatic compression (IPC) systems are applied to subject legs and comprise of a controller, associated tubing set and single patient use disposable leg sleeves. The disposable sleeves are latex free and contain air bladder(s) that are inflated by the controller to provide compression to the legs/feet. These devices are designed to increase venous blood flow in at risk patients in order to help prevent Venous ThromboEmbolism (VTE), including Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Baseline blood flow (hemodynamic) measurements will be obtained via ultrasound for all enrolled subjects. Following baseline measurements, compression will be applied and blood flow (hemodynamic) measurements will be repeated via ultrasound. Receives: Device: Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Velocity
Blood Velocity (Baseline, Peak) will be assessed via ultrasound in the popliteal and femoral veins.
Measured: baseline, +10 minutes
Time Average Mean Velocity
Time Average Mean Velocity (Baseline, Augmented) will be assessed via ultrasound in the popliteal and femoral veins.
Measured: baseline, +10 minutes
Secondary outcomes (1)
Total Volume Flow
Total Volume Flow (Baseline, Augmented) will be assessed via ultrasound in the popliteal and femoral veins.
Measured: baseline, +10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardinal Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fedor Lurie, Principal investigator, Jobst Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945186
- Sponsor's protocol ID
- 450.30
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System With Cardinal Health Element Compression Sleeves
- ClinicalTrials.gov ID
- NCT05945186
- Acronym / sponsor ID
- 450.30
- Conditions
- Hemodynamics
- Keywords
- Hemodynamics, Blood Flow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Cardinal HealthIndustry (pharma, biotech, devices)
- Study start
- Aug 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 14 Jul 2023 (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.
This study is being conducted to evaluate the hemodynamic performance (i.e. flow of blood) in the legs using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves.
Detailed description
This study is being conducted to evaluate hemodynamic performance using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves. The study is intended to confirm the system's ability to increase venous blood flow over baseline as measured by blood velocity, time average mean velocity and total volume flow, in both the femoral and popliteal veins.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)Baseline blood flow (hemodynamic) measurements will be obtained via ultrasound for all enrolled subjects. Following baseline measurements, compression will be applied and blood flow (hemodynamic) measurements will be repeated via ultrasound. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be ≥18 years and ≤ 89 years of age.
- Subject must be able to speak and read English.
- Subject must have both legs fully intact (cannot be an amputee) with normal function.
- Subject must be able to commit to the full study duration (approximately 1-2 hours of uninterrupted time).
- Subject legs must fit into the provided knee length compression sleeves (<32").
Key exclusion criteria (13 listed)
- Subject is currently pregnant or breastfeeding.
- Subject has a positive COVID history within the previous 6 months.
- Subject presents with
- Subject who, in the opinion of the investigator, is not an appropriate candidate for the study
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 |
|---|---|---|
| Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)External intermittent pneumatic compression (IPC) systems are applied to subject legs and comprise of a controller, associated tubing set and single patient use disposable leg sleeves. The disposable sleeves are latex free and contain air bladder(s) that are inflated by the controller to provide compression to the legs/feet. These devices are designed to increase venous blood flow in at risk patients in order to help prevent Venous ThromboEmbolism (VTE), including Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). | Device | Single Arm |
Primary outcome
Blood Velocity
Time frame: baseline, +10 minutes
Blood Velocity (Baseline, Peak) will be assessed via ultrasound in the popliteal and femoral veins.
Time Average Mean Velocity
Time frame: baseline, +10 minutes
Time Average Mean Velocity (Baseline, Augmented) will be assessed via ultrasound in the popliteal and femoral veins.
1 secondary outcome
Total Volume Flow
Time frame: baseline, +10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- 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.
Fedor Lurie principal investigator
Jobst Vascular Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves) in people with Hemodynamics, run by Cardinal Health at 1 site in United States.
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 13 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 14 Jul 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria Colasanto (508-618-3574, victoria.colasanto@cardinalhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Velocity (time frame: baseline, +10 minutes). 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 14 Jul 2023.