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

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

Study Overview

• Status: Completed
• Conditions: Lymphedema; Edema; Venous Insufficiency of Leg; Chronic Venous Insufficiency
• Intervention / Treatment: Diagnostic test: Insight Pro Device for Diagnosis

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.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94607
      • Koya Medical, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

(Test Group) - Up to 50 subjects will be enrolled with unilateral or bilateral edema in the upper or lower extremity.

(Control Group) Up to 50 patients will be enrolled from a healthy volunteer group as a control, with no edema.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Test group; 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; Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders
Control group; 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; Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Koya Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Actual): August 28, 2024
• Study Completion (Actual): December 4, 2025

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Lymphedema; Edema; Diagnosis
• Other Study ID Numbers: KCT 011 (VOLGA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No