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

NCT ID: NCT05628688

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-08
• Study Completion Date: 2025-12-04

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group

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

Insight Pro Device for Diagnosis

Intervention Type: DIAGNOSTIC_TEST

Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders

Test group

Up to 50 subjects will be enrolled with unilateral or bilateral edema in the upper or lower extremity.

Insight Pro Device for Diagnosis

Intervention Type: DIAGNOSTIC_TEST

Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders

Interventions

Insight Pro Device for Diagnosis

Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Koya Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Koya Medical, Inc.

Oakland, California, United States

Countries

United States

Other Identifiers

KCT 011 (VOLGA)

Identifier Type: -

Identifier Source: org_study_id