A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
Completed
Conditions studied: Lymphedema, Chronic Venous Insufficiency, Edema, Venous Insufficiency of Leg
In brief
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
Key facts
- Study ID
- NCT05628688
- Run by
- Koya Medical, Inc.
- People needed
- 67
- Starts
- 2023-08-08
- Expected to finish
- 2025-12-04
- Last updated by the study team
- 2025-12-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Koya Medical, Inc. — Oakland, California, United States
Full record on ClinicalTrials.gov
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