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

Exclusion Criteria

• •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