RecruitingNot ApplicableNCT06418282

Clinical 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

Sponsor

Koya Medical, Inc.

Enrollment

100 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Lymphedema Phlebolymphedema

Summary

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria4

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 Criteria21

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