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

Exclusion Criteria

• •● Inability or unwillingness to participate in all aspects of the study protocol and/or failure 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 (\< 3 months since completion of chemotherapy, radiation therapy, or primary surgery for the cancer)
• •* Patients with cardiac arrhythmia with pacemakers or other implanted electronic equipment
• •* 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 2 months
• •* 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 device during the past 30 days