Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
- Conditions
- PhlebolymphedemaLymphedemaChronic Venous Insufficiency
- Interventions
- Device: Dayspring
- Registration Number
- NCT06418282
- Lead Sponsor
- Koya Medical, Inc.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dayspring, Non-Pneumatic Active Compression Device (NPCD) Dayspring The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner.
- Primary Outcome Measures
Name Time Method Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events) 6 months Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
Lymphedema Overall Quality of Life and Patient Survey 6 months The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 3. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 6
Mobility (daily steps using a pedometer) 6 months Mobility (daily steps using a pedometer)
- Secondary Outcome Measures
Name Time Method Lower extremity edema response (limb girth reduction) 6 months Lower extremity edema response (limb girth reduction)
Venous Clinical Severity Score (VCSS) 6 months Venous Clinical Severity Score (VCSS) scored on severity from None (0), Mild (1), Moderate (2) to Severe (3). Higher score means a worse outcome
LE Functional Index (LEFI) 6 months LE Functional Index (LEFI)
Safety/Adverse Events 6 months As assessed by reported adverse events
Trial Locations
- Locations (1)
Glenn Jacobowitz
🇺🇸New York, New York, United States