A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)

Inclusion Criteria: Test group -

• Males and females ≥ 18 years of age
• Willing to sign the informed consent and deemed capable of following the studyprotocol
• Subjects must have primary or secondary unilateral or bilateral upper or lowerextremity edema
• At the time of initial evaluation, individuals must be at least 3 months post-surgery,chemotherapy and/or radiation treatment for cancer if applicable Control group -
• Males and females ≥ 18 years of age
• Willing to sign the informed consent and deemed capable of following the studyprotocol
• Subjects must not have primary or secondary edema and self-describe general healthy

Exclusion Criteria:

• ● Inability or unwillingness to participate in all aspects of the study protocoland/or failure to provide informed consent
• Patients with exam results that would prevent safe and effective use of the studydevice (cellulitis, open-wounds, healing-wounds, etc.)
• Diagnosis of active or recurrent cancer (< 3 months since completion ofchemotherapy, radiation therapy, or primary surgery for the cancer)
• Patients with cardiac arrhythmia with pacemakers or other implanted electronicequipment
• Patients must not have implanted metal hardware in the limbs
• Patients undergoing external defibrillation
• Diagnosis of Acute infection (in the last four weeks)
• Diagnosis of acute thrombophlebitis (in last 2 months)
• Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 2months
• Diagnosis of congestive heart failure (uncontrolled)
• Diagnosis of chronic kidney disease with acute renal failure
• Women who are pregnant, planning a pregnancy or nursing at study entry
• Participation in any clinical trial of an investigational substance or deviceduring the past 30 days