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.
Study Type
OBSERVATIONAL
Enrollment
67
Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders
Koya Medical, Inc.
Oakland, California, United States
Edema Volume
Edema Volume detection by difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.
Time frame: Acute - At day 0
Fibrosis
Durometer detection or Skin hardness (fibrosis) difference through a durometer measurement.
Time frame: Acute - At day 0
Safety/AEs
Safety during use (via adverse event reporting)
Time frame: Acute - At day 0
LymVAS
Correlation with quality-of-life objective parameters using a lymphedema visual analog scale
Time frame: Acute - At day 0
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