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NCT05628688
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
Conditions: Lymphedema, Chronic Venous Insufficiency, Edema, Venous Insufficiency of Leg
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 100
Sponsor: Koya Medical, Inc.
Summary
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
Eligibility Criteria
Inclusion Criteria:Test group -Males and females ≥ 18 years of ageWilling to sign the informed consent and deemed capable of following the study protocolSubjects must have primary or secondary unilateral or bilateral upper or lower extremity edemaAt the time of initial evaluation, individuals must be at least 3 months post-surgery, chemotherapy and/or radiation treatment for cancer if applicableControl group -Males and females ≥ 18 years of ageWilling to sign the informed consent and deemed capable of following the study protocolSubjects must not have primary or secondary edema and self-describe general healthyExclusion Criteria:● Inability or unwillingness to participate in all aspects of the study protocol and/or failure to provide informed consentPatients 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 equipmentPatients must not have implanted metal hardware in the limbsPatients undergoing external defibrillationDiagnosis 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 monthsDiagnosis of congestive heart failure (uncontrolled)Diagnosis of chronic kidney disease with acute renal failureWomen who are pregnant, planning a pregnancy or nursing at study entryParticipation in any clinical trial of an investigational substance or device during the past 30 days
Source: ClinicalTrials.gov (NCT05628688). StuddyBuddy aggregates publicly available trial information.