Lymphedema Clinical Trial
Official title:
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
6. Clinical Hypotheses 1. The Insight Pro device can detect a difference in extracellular fluid volume through bioimpedance and dielectric constant measurement. 2. The Insight Pro device can detect a difference in skin hardness or fibrositis through a durometer measurement. 3. The Insight Pro device is safe for use as assessed by adverse events. ;
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