Evaluating the Insight Pro Device for Lymphatic and Venous Disorders
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
Koya Medical, Inc. · NCT05628688
This study is testing a new device to see if it can safely and effectively detect lymphatic and venous problems like swelling and poor blood flow in people with and without these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Koya Medical, Inc. (industry) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Oakland, California) |
| Trial ID | NCT05628688 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of the Insight Pro Device in detecting lymphatic and venous disorders such as lymphedema and chronic venous insufficiency. It involves measuring extracellular fluid volume and skin hardness using advanced bioimpedance and durometer techniques. Participants will include individuals with edema as well as healthy controls to compare results. The study will monitor adverse events to ensure the device's safety during use.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unilateral or bilateral extremity edema who are at least three months post-cancer treatment.
Not a fit: Patients with active or recurrent cancer, open wounds, or those unable to participate in the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive and effective diagnostic tool for patients suffering from lymphatic and venous disorders.
How similar studies have performed: While this approach is innovative, similar studies evaluating bioimpedance for fluid detection have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oakland, California
- Koya Medical, Inc. — Oakland, California, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphedema, Chronic Venous Insufficiency, Edema, Venous Insufficiency of Leg