Clinical trial NCT06418282: Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Phlebolymphedema
Lymphedema
Chronic Venous Insufficiency
Lead sponsor: Koya Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed description: 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: 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

Primary outcomes:
measure: Lymphedema Overall Quality of Life and Patient Survey
timeFrame: 6 months
measure: Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
timeFrame: 6 months
measure: Mobility (daily steps using a pedometer)
timeFrame: 6 months
Secondary outcomes:
measure: Lower extremity edema response (limb girth reduction)
timeFrame: 6 months
measure: LE Functional Index (LEFI)
timeFrame: 6 months
measure: Venous Clinical Severity Score (VCSS)
timeFrame: 6 months
measure: Safety/Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Glenn Jacobowitz
state: New York
Study officials:
References: