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

Koya Medical

Status: Enrolling

Conditions: Phlebolymphedema; Lymphedema; Chronic Venous Insufficiency

Treatments: Device: Dayspring

Study type: Interventional

Funder types: Industry

Identifiers

NCT06418282

KCT 013 (GRANDE)

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Dayspring, Non-Pneumatic Active Compression Device (NPCD)

Experimental group

Description:

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.

Treatment:

Device: Dayspring