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

Study Overview
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Brief Summary
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To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.

Detailed Description
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6. 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.

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

Conditions
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Lymphedema, Chronic Venous Insufficiency, Edema, Venous Insufficiency of Leg

Intervention / Treatment
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* Diagnostic Test: Insight Pro Device for Diagnosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test group<br>Up to 50 subjects will be enrolled with unilateral or bilateral edema in the upper or lower extremity. | Diagnostic Test: Insight Pro Device for Diagnosis<br>* Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders<br>|
| Control group<br>Up to 50 patients will be enrolled from a healthy volunteer group as a control, with no edema. | Diagnostic Test: Insight Pro Device for Diagnosis<br>* Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edema Volume | Edema Volume detection by difference in extracellular fluid volume through bioimpedance and dielectric constant measurement. | Acute - At day 0 | 
| Fibrosis | Durometer detection or Skin hardness (fibrosis) difference through a durometer measurement. | Acute - At day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/AEs | Safety during use (via adverse event reporting) | Acute - At day 0 | 
| LymVAS | Correlation with quality-of-life objective parameters using a lymphedema visual analog scale | Acute - At day 0 |