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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorKoya Medical, Inc.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dayspring

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators