Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System
Status unconfirmed · Not applicable
Conditions studied: Hemodynamics
In brief
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.
Key facts
- Study ID
- NCT05945186
- Run by
- Cardinal Health
- People needed
- 19
- Starts
- 2023-08-01
- Expected to finish
- 2023-11-01
- Last updated by the study team
- 2023-07-14
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- - 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
Where it is running
- Jobst Vascular Institute — Toledo, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.