Actively Recruiting
An Open-label, Multi-center, Prospective VA Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
Led by Koya Medical, Inc. · Updated on 2026-05-04
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) called Dayspring for people with lymphedema or phlebolymphedema, conditions related to chronic venous insufficiency affecting the lower limbs. The study is open-label and conducted at multiple centers, focusing on how this device may impact health outcomes and costs. Participants will use the Dayspring device, an FDA-cleared active wearable compression garment that applies controlled, sequential pressure from the lower to upper parts of the limb in cycles. This device is programmable and designed to help manage symptoms by improving blood and lymph flow. The study lasts for six months and includes monitoring the device’s performance and effects on the participants. Throughout the study, participants will be assessed for changes in limb swelling, mobility measured by daily steps, venous clinical severity, and hospital resource use related to adverse events. Safety and any side effects will also be tracked. The total study duration for each participant is six months, with regular evaluations to monitor progress and health status.
CONDITIONS
Brief Title
Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females 18 years of age or older
- Able and willing to sign informed consent and follow study protocol
- Diagnosis of unilateral or bilateral lower extremity edema or lymphedema/phlebolymphedema due to chronic venous insufficiency
- Medical clearance with diagnostic confirmation through venous duplex to rule out deep vein thrombosis and reflux
You will not qualify if you...
- Unable or unwilling to participate in all study procedures or provide informed consent
- History or presence of systemic disorder increasing risk from sequential compression therapy
- Diagnosed cognitive or physical impairment interfering with device use
- Non-ambulatory individuals
- Female with BMI over 34 (approx. 5'4" height, 200 lbs.)
- Male with BMI over 34 (approx. 5'9" height, 230 lbs.)
- Maximum limb circumference exceeding limits (patella 58 cm, gluteal fold 75 cm)
- Diagnosis of lipedema
- Active or recurrent cancer within 3 months of treatment completion
- Active infection within the last 4 weeks
- Active/open wounds or ulcers
- Acute thrombophlebitis within last 2 months
- Pulmonary embolism or deep vein thrombosis within last 6 months
- Pulmonary edema
- Uncontrolled congestive heart failure
- Chronic kidney disease with acute renal failure
- Epilepsy
- Poorly controlled asthma
- Any condition where increased venous and lymphatic return is undesirable
- Pregnant, planning pregnancy, or nursing women
- Participation in another investigational clinical trial within past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants use the Dayspring Non-Pneumatic Active Compression Device (NPCD) to manage lymphedema/phlebolymphedema.
Trial Site Locations
Total: 1 location
1
Glenn Jacobowitz
New York, New York, United States, 10016
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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