Koya Medical, Inc.
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
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…
NPCD
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