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

• Clinical Hypotheses

• The Insight Pro device can detect a difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.
• The Insight Pro device can detect a difference in skin hardness or fibrositis through a durometer measurement.
• The Insight Pro device is safe for use as assessed by adverse events.

Inclusion criteria

Test group -

• Males and females ≥ 18 years of age
• Willing to sign the informed consent and deemed capable of following the study protocol
• Subjects must have primary or secondary unilateral or bilateral upper or lower extremity 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 study protocol
• 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 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