Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

Recruiting now · Not applicable

Conditions studied: Phlebolymphedema, Lymphedema, Chronic Venous Insufficiency

In brief

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

Key facts

Study ID

NCT06418282

Run by

Koya Medical, Inc.

People needed

100

Starts

2024-05-13

Expected to finish

2027-12-31

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females ≥ 18 years of age
• Capable and willing to sign the informed consent and deemed capable of following the study protocol
• Subjects must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency
• Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux

You may not qualify if…

• Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
• Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
• Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device
• Non-ambulatory individuals
• Female: BMI > 34 (5'4", 200 lbs.)
• Male: BMI > 34 (5'9", 230 lbs.)
• (Max circumference at patella 58 cm; Max circumference at gluteal fold 75 cm)
• Diagnosis of lipedema
• Diagnosis of active or recurrent cancer (< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
• Diagnosis of acute infection (in the last four weeks)
• Diagnosis of active/open wound/ulcer
• Diagnosis of acute thrombophlebitis (in last 2 months)
• Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
• Diagnosis of pulmonary edema
• Diagnosis of congestive heart failure (uncontrolled/uncompensated)
• Diagnosis of chronic kidney disease with acute renal failure
• Diagnosis of epilepsy
• Subjects with poorly controlled asthma
• Any condition where increased venous and lymphatic return is undesirable
• Women who are pregnant, planning a pregnancy or nursing at study entry
• Participation in any clinical trial of an investigational substance or device during the past 30 days

Where it is running

• Glenn Jacobowitz — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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