NCT06418282 · Koya Medical, Inc.
Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
(GRANDE)
What this study is about
An where both patients and doctors know the treatment given, multi-center, forward-looking VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
View original scientific 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
Interventions
DEVICE
Dayspring
NPCD
Primary outcome measures
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
Time frame: 6 months
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
Mobility (daily steps using a pedometer)
Time frame: 6 months
Mobility (daily steps using a pedometer)
Venous Clinical Severity Score (VCSS)
Time frame: 180 days
Venous Clinical Severity Score (VCSS)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations