PhlebolymphedemaGRANDENCT06418282
Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
A study testing Dayspring in people with Phlebolymphedema and Lymphedema, run by Koya Medical, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Phlebolymphedema, Lymphedema, Chronic Venous Insufficiency
- What is being tested?
- Dayspring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 21Show fewer
- (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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Glenn Jacobowitz
New York, New York, 10016
Glenn Jacobowitz, MD, 415-851-0337, clinical@koyamedical.com
About this study
Official title: 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
Read the 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
- Conditions
- Phlebolymphedema, Lymphedema, Chronic Venous Insufficiency
- Being tested
- Dayspring
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DayspringDevice
NPCD
| Study group | Role | What they receive |
|---|---|---|
| Dayspring, Non-Pneumatic Active Compression Device (NPCD) | Experimental | 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. Receives: Device: Dayspring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Mobility (daily steps using a pedometer)
Mobility (daily steps using a pedometer)
Measured: 6 months
Venous Clinical Severity Score (VCSS)
Venous Clinical Severity Score (VCSS)
Measured: 180 days
Secondary outcomes (2)
Lower extremity edema response (limb girth reduction)
Lower extremity edema response (limb girth reduction)
Measured: 6 months
Safety/Adverse Events
As assessed by reported adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start13 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhlebolymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koya Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418282
- Sponsor's protocol ID
- KCT 013 (GRANDE)
- Acronym
- GRANDE
- Status last verified
- Dec 2025
- First submitted
- 13 May 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06418282
- Acronym / sponsor ID
- GRANDE / KCT 013 (GRANDE)
- Conditions
- Phlebolymphedema, Lymphedema, Chronic Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Koya Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dayspring, Non-Pneumatic Active Compression Device (NPCD) | Experimental | Device: DayspringThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DayspringNPCD | Device | Dayspring, Non-Pneumatic Active Compression Device (NPCD) |
Primary outcome
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)
2 secondary outcomes
Lower extremity edema response (limb girth reduction)
Time frame: 6 months
Safety/Adverse Events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dayspring in people with Phlebolymphedema and Lymphedema, run by Koya Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.