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Compression Device

Cross over Device (PCD or Dayspring - alternate to first group) for 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

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
  • Chronic Venous Insufficiency
  • Leg Lymphedema
  • Venous Insufficiency
  • Lower Limb Lymphedema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

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

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
~40 spots leftby Sep 2025
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