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

Recruiting

• Conditions: Lymphedema; Edema; Chronic Venous Insufficiency; Venous Insufficiency of Leg

• Registration Number: NCT05628688
• Lead Sponsor: Koya Medical, Inc.

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.

Study Timeline

• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-29
• Study Start: 2023-08-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-16
• Primary Completion: 2024-08-28
• Study Completion: 2024-08-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Edema Volume	Acute - At day 0	Edema Volume detection by difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.
Fibrosis	Acute - At day 0	Durometer detection or Skin hardness (fibrosis) difference through a durometer measurement.

Secondary Outcome Measures

Name	Time	Method
Safety/AEs	Acute - At day 0	Safety during use (via adverse event reporting)
LymVAS	Acute - At day 0	Correlation with quality-of-life objective parameters using a lymphedema visual analog scale

Trial Locations

Locations (1)

Koya Medical, Inc.; 🇺🇸 Oakland, California, United States