Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study

Inclusion Criteria: * Males and females ≥ 18 years of age * Willing to sign the informed consent and deemed capable of following the study protocol * Subjects must have a diagnosis of primary or secondary unilateral or bilateral upper extremity edema Exclusion Criteria: * Individuals with a history or presence of a systemic disorder or condition that could place the patient at increased risk from sequential compression therapy * Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent * Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.) * Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer * Diagnosis of Acute infection (in the last two weeks) * Diagnosis of acute thrombophlebitis (in last 2 months) * Diagnosis of peripheral arterial disease (PAD): PAD is defined as an Ankle Brachial Index (ABI), of 0.7 or lower * Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months * Diagnosis of pulmonary edema * Diagnosis of congestive heart failure (uncontrolled) * Diagnosis of chronic kidney disease * Diagnosis of epilepsy * Patients 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