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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) — VOLGA  

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)

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05628688
Study type Observational
Source Koya Medical, Inc.
Contact
Status Recruiting
Phase
Start date August 8, 2023
Completion date August 28, 2024
View Details
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