Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System

Launched by CARDINAL HEALTH · Jul 13, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System" is exploring how well a new compression device can help improve blood flow in the legs. This device, called the Kendall SCD SmartFlow™ system, works with special compression sleeves designed to fit on the legs. The goal is to see if using this system can enhance the flow of blood, which is important for overall leg health.

To participate in this study, individuals must be between 18 and 89 years old, able to read and speak English, and have both legs in good condition (no amputations or serious leg issues). Participants should also be able to commit to about 1-2 hours for the study. However, people who are pregnant, have certain leg conditions, or a history of blood clots may not be eligible. Those who join the study will wear the compression sleeves and be monitored for how their blood flows in the legs. This trial is currently recruiting participants, and it's a great opportunity to contribute to research that could benefit many others.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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