Actively Recruiting
Clinical 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
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 the study protocol
- Diagnosed with unilateral or bilateral lower extremity edema or lymphedema/phlebolymphedema from chronic venous insufficiency
- Medical clearance confirmed by venous duplex to rule out deep vein thrombosis and reflux
You will not qualify if you...
- Unable or unwilling to participate fully or provide informed consent
- History or presence of systemic disorders increasing risk from compression therapy
- Cognitive or physical impairments interfering with device use
- Non-ambulatory status
- Female with BMI greater than 34 (5'4", 200 lbs.)
- Male with BMI greater than 34 (5'9", 230 lbs.)
- Maximum circumference at patella over 58 cm or at gluteal fold over 75 cm
- Diagnosis of lipedema
- Active or recurrent cancer within 3 months of treatment completion
- Acute infection within the last 4 weeks
- Active/open wounds or ulcers
- Acute thrombophlebitis within last 2 months
- Pulmonary embolism or deep vein thrombosis within previous 6 months
- Pulmonary edema
- Uncontrolled or uncompensated congestive heart failure
- Chronic kidney disease with acute renal failure
- Epilepsy
- Poorly controlled asthma
- Any condition where increased venous and lymphatic return is not advisable
- Women who are pregnant, planning pregnancy, or nursing at study entry
- Participation in another clinical trial within the past 30 days
AI-Screening
AI-Powered Screening
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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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