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

NCT05628688 | Completed FDA Device

• 1 other identifier: KCT 011 (VOLGA)
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Insufficiency of Leg; Lymphedema; Chronic Venous Insufficiency; Edema

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Safety/AEs

  Acute - At day 0

• LymVAS

  Acute - At day 0

Study Arms (2)

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

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

Interventions

Insight Pro Device for Diagnosis DIAGNOSTIC_TEST

Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders

Control group; Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• ● 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

Sponsors & Collaborators

• Koya Medical, Inc.: lead

Study Sites (1)

Koya Medical, Inc.

Oakland, California, 94607, United States

Location

MeSH Terms

Conditions

Lymphedema; Edema

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 29, 2022
• Study Start: August 8, 2023
• Primary Completion: August 28, 2024
• Study Completion: December 4, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)