Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

Launched by KOYA MEDICAL, INC. · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new portable device designed to help treat lymphedema and phlebolymphedema, conditions that cause swelling in the legs due to fluid buildup. The study aims to see how effective this device is and how it might save costs in treatment. They are currently recruiting participants who are at least 18 years old and have swelling in one or both legs, which is related to chronic venous insufficiency, a condition where the veins have trouble sending blood back to the heart.

To join the study, participants must be able to give their consent and follow the study instructions. However, some individuals may not qualify, such as those with certain health issues or specific conditions like cancer or active infections. Participants will have the chance to use the device and contribute to understanding its benefits. Overall, this study could help improve treatment options for people with these conditions, making it an important step forward in care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males and females ≥ 18 years of age
• • Capable and willing to sign the informed consent and deemed capable of following the study protocol
• • Subjects must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency
• • Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux
• Exclusion Criteria:
• • Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
• • Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
• • Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device
• • Non-ambulatory individuals
• • Female: BMI \> 34 (5'4", 200 lbs.)
• • Male: BMI \> 34 (5'9", 230 lbs.)
• • (Max circumference at patella 58 cm; Max circumference at gluteal fold 75 cm)
• • Diagnosis of lipedema
• • Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
• • Diagnosis of acute infection (in the last four weeks)
• • Diagnosis of active/open wound/ulcer
• • Diagnosis of acute thrombophlebitis (in last 2 months)
• • Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
• • Diagnosis of pulmonary edema
• • Diagnosis of congestive heart failure (uncontrolled/uncompensated)
• • Diagnosis of chronic kidney disease with acute renal failure
• • Diagnosis of epilepsy
• • Subjects with poorly controlled asthma
• • Any condition where increased venous and lymphatic return is undesirable
• • 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