A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema. To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.

Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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 upper extremity edema

You may not be if

Individuals with a history or presence of a systemic disorder or condition that could place the subject 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
Subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
Subjects must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
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 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 during the past 30 days

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

What this study is about