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

Not Applicable

Recruiting

• Conditions: Phlebolymphedema; Lymphedema; Chronic Venous Insufficiency

• 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

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-13
• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-16
• Study First Posted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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
Safety/Adverse Events	6 months	As assessed by reported adverse events
LE Functional Index (LEFI)	6 months	LE Functional Index (LEFI)

Trial Locations

Locations (1)

Glenn Jacobowitz; 🇺🇸 New York, New York, United States