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

Recruiting

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

Who can join

Ages 18 to 100 · All sexes

Full 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

About the study

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

What is being tested

Sponsor: Koya Medical, Inc. · Participants: 100 · Started: May 13, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06418282

Locations in the U.S.

New YorkGlenn Jacobowitz, New York

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.