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Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System
N/A
Recruiting
Led By Fedor Lurie
Research Sponsored by Cardinal Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, +10 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new device and special sleeves that squeeze the legs to help improve blood flow. It targets people who need better blood circulation in their legs by applying pressure to move blood through the veins more effectively.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, +10 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, +10 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood Velocity
Time Average Mean Velocity
Secondary study objectives
Total Volume Flow
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Cardinal HealthLead Sponsor
10 Previous Clinical Trials
2,148 Total Patients Enrolled
Fedor LuriePrincipal InvestigatorJobst Vascular Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a leg condition, like a skin rash or open wound, that would be affected by wearing the study sleeves.You have a condition called arteriosclerosis or other issues with your blood vessels that cause reduced blood flow. This can be determined by absence of pulses in your feet or a history of leg pain that gets worse with activity.You have a history of blood clots in your veins or lungs.You have a condition called May-Thurner Syndrome.You have swelling in your legs or fluid buildup in your lungs from heart failure.You have a condition where blood flows back into your veins, either in the surface or deep veins.You have a leg deformity.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.