NCT05628688

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 67 (actual)
• Sponsor: Koya Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Lymphedema
• Chronic Venous Insufficiency
• Edema
• Venous Insufficiency of Leg

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Insight Pro Device for Diagnosis	Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders

Timeline

• Start date: 2023-08-08
• Primary completion: 2024-08-28
• Completion: 2025-12-04
• First posted: 2022-11-29
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study