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

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

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 Overview

• Status: Recruiting
• Conditions: Lymphedema; Chronic Venous Insufficiency; Phlebolymphedema
• Intervention / Treatment: Device: Dayspring

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Glenn Jacobowitz
      • Contact: Glenn Jacobowitz, MD; Phone Number: 415-851-0337; Email: clinical@koyamedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dayspring, Non-Pneumatic Active Compression Device (NPCD); 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.	Device: Dayspring; NPCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphedema Overall Quality of Life and Patient Survey	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	6 months
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)	Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)	6 months
Mobility (daily steps using a pedometer)	Mobility (daily steps using a pedometer)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower extremity edema response (limb girth reduction)	Lower extremity edema response (limb girth reduction)	6 months
LE Functional Index (LEFI)	LE Functional Index (LEFI)	6 months
Venous Clinical Severity Score (VCSS)	Venous Clinical Severity Score (VCSS) scored on severity from None (0), Mild (1), Moderate (2) to Severe (3). Higher score means a worse outcome	6 months
Safety/Adverse Events	As assessed by reported adverse events	6 months

Collaborators and Investigators

• Sponsor: Koya Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 13, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Lymphatic Diseases; Lymphedema; Venous Insufficiency
• Other Study ID Numbers: KCT 013 (GRANDE)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No