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Compression Device
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema (TEAYS Trial)
N/A
Waitlist Available
Research Sponsored by Koya Medical, Inc.
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 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new wearable device called Dayspring that helps reduce leg swelling without using air pressure. It is aimed at people with chronic leg swelling (lymphedema) to see if it improves their condition and quality of life.
Eligible Conditions
- Lymphedema
- Venous Insufficiency
- Swollen Leg
- Chronic Venous Insufficiency
- Lower Limb Lymphedema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
LYMQOL
Limb volume reduction or maintenance
Therapy adherence tracking
Secondary study objectives
Patient survey on preference
Safety/AEs
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dayspring, Non-Pneumatic Active Compression Device (NPCD)Experimental Treatment1 Intervention
The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner.
Group II: Advanced Pneumatic Compression Device (APCD)Active Control1 Intervention
A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cross over Device (PCD or Dayspring - alternate to first group)
2022
N/A
~130
Find a Location
Who is running the clinical trial?
Koya Medical, Inc.Lead Sponsor
6 Previous Clinical Trials
312 Total Patients Enrolled
6 Trials studying Lymphedema
312 Patients Enrolled for Lymphedema