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

Eligibility Criteria

• * 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
• * 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