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

Launched by KOYA MEDICAL, INC. · Nov 16, 2022

Keywords

ClinConnect Summary

The VOLGA trial is studying a device called the Insight® Pro, which aims to help detect problems in the lymphatic and venous systems, particularly conditions like lymphedema (swelling caused by lymph fluid) and chronic venous insufficiency (poor blood flow in the veins). The researchers want to find out if this device is safe and effective for people experiencing these issues. The trial is currently looking for participants aged 18 and older who have swelling in their arms or legs, either from a known condition or after surgery or cancer treatment. There’s also a control group for people who are generally healthy and do not have any swelling.

If you decide to join the study, you will need to sign an agreement to participate and follow the study rules. Participants will be closely monitored while using the device to ensure it's safe. However, there are some important health criteria to keep in mind. For example, individuals with certain infections, heart problems, or those who have recently had cancer treatment may not be eligible. Overall, this trial is an exciting opportunity for those experiencing specific swelling issues to potentially benefit from new technology while contributing to important medical research.

Gender

ALL

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