A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema

Inclusion Criteria:

• Males and females ≥ 18 years of age

• Willing to sign the informed consent and deemed capable of following the studyprotocol

• Subjects must have a diagnosis of primary or secondary unilateral upper extremityedema

Exclusion Criteria:

• Individuals with a history or presence of a systemic disorder or condition thatcould place the subject at increased risk from sequential compression therapy

• Inability or unwillingness to participate in all aspects of study protocol and/orinability to provide informed consent

• Subjects with exam results that would prevent safe and effective use of the studydevice (cellulitis, open-wounds, healing-wounds, etc.)

• Subjects must not have any diagnosed cognitive or physical impairment that wouldinterfere with use of the device

• Diagnosis of lipedema

• Diagnosis of active or recurrent cancer (< 3 months since completion ofchemotherapy, radiation therapy or primary surgery for the cancer)

• Diagnosis of Acute infection (in the last four weeks)

• Diagnosis of acute thrombophlebitis (in last 6 months)

• 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 with 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 duringthe past 30 days