A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
NCT05628688 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67
Last updated 2025-12-12
Summary
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
Conditions
- Lymphedema
- Chronic Venous Insufficiency
- Edema
- Venous Insufficiency of Leg
Interventions
- DIAGNOSTIC_TEST
-
Insight Pro Device for Diagnosis
Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders
Sponsors & Collaborators
-
Koya Medical, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-08-08
- Primary Completion
- 2024-08-28
- Completion
- 2025-12-04
- FDA Device
- Yes
Countries
- United States
Study Locations
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