Portable Compression Device for Lymphedema

(GRANDE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Koya Medical, Inc.

Disqualifiers: Cancer, Infection, Thrombophlebitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of a new portable compression device (NPCD, also known as Dayspring or Koya Dayspring) for individuals with lymphedema, a condition characterized by swelling, usually in the legs, due to fluid build-up. The device aims to move fluid from the legs back towards the body to reduce swelling. It may benefit those with swelling in one or both legs caused by vein issues. Participants must be able to walk and must not have any infections or heart conditions that compression could worsen. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for lymphedema.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that this device is safe for lymphedema?

Research has shown that the Dayspring Non-Pneumatic Compression Device (NPCD) is safe for use. The FDA has approved this device, indicating it has passed crucial safety checks for medical use. Over 11 clinical studies have tested its safety and effectiveness.

Results demonstrate that the Dayspring device reduces swelling in patients with lymphedema, a condition causing fluid build-up and swelling, often in the arms or legs. These studies reported no serious side effects or unexpected problems, suggesting patients tolerate the device well.

Overall, the evidence supports the safety of the Dayspring device for managing lymphedema and similar conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for lymphedema, which often involve manual lymphatic drainage or pneumatic compression devices, the Dayspring Non-Pneumatic Active Compression Device (NPCD) stands out due to its innovative design. This wearable device is segmental and programmable, delivering controlled, sequential pressure along the limb in a cyclic manner. This approach provides a more targeted and customizable treatment option, potentially improving comfort and efficacy for patients. Researchers are excited about the NPCD because it offers a non-invasive, user-friendly alternative that could enhance patient compliance and quality of life.

What evidence suggests that this device is effective for lymphedema?

Research has shown that the Dayspring Non-Pneumatic Active Compression Device (NPCD), used by participants in this trial, could help treat lymphedema. Studies have found that the NPCD reduces limb swelling more effectively than traditional air-based compression devices. Users of the Dayspring system also reported an improved quality of life. The device gently squeezes the affected limb, enhancing blood flow and reducing swelling. Overall, the Dayspring NPCD effectively manages lymphedema symptoms and improves mobility. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like lymphedema or chronic venous insufficiency, which cause swelling due to fluid buildup. Participants should be interested in trying a new portable device designed to help manage their condition.

Inclusion Criteria

I can and will sign the consent form and follow the study rules.

I have swelling in my legs due to poor blood flow or lymph issues.

I've been cleared of having deep vein thrombosis or vein issues after a specific vein test.

Exclusion Criteria

I cannot walk by myself.

My BMI is over 34.

I have been diagnosed with fluid in my lungs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema

6 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NPCD

Trial Overview The study is testing the effectiveness and cost-efficiency of a new device called Dayspring. It's an active compression system that patients can use to potentially reduce swelling associated with lymphedema/phlebolymphedema.

How Is the Trial Designed?

Group I: Dayspring, Non-Pneumatic Active Compression Device (NPCD) Experimental Treatment 1 Intervention

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.

NPCD is already approved in United States for the following indications:

Approved in United States as Dayspring for:

• Lymphedema
• Phlebolymphedema
• Chronic Venous Insufficiency (CVI)

Who Is Running the Clinical Trial?

Koya Medical, Inc.

Lead Sponsor

Trials

7

Recruited

430+

Published Research Related to This Trial

In a study involving 50 women with breast cancer-related lymphedema, the novel nonpneumatic compression device (NPCD) significantly reduced limb edema volume by 64.6%, compared to a 27.7% reduction with the advanced pneumatic compression device (APCD).

The NPCD also led to higher patient adherence (95.6% vs 49.8%) and satisfaction (90% vs 14%) compared to the APCD, indicating it is a more user-friendly option for self-care in lymphedema treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of a novel nonpneumatic active compression device for treating breast cancer-related lymphedema: A multicenter randomized, crossover trial (NILE). Rockson, SG., Whitworth, PW., Cooper, A., et al.[2022]

In a study of 14 subjects aged 65 and older with breast cancer-related lymphedema, the novel nonpneumatic compression device (NPCD) led to a significant mean decrease in limb edema of 100.3%, compared to only 2.9% with the traditional pneumatic compression device (APCD).

Patients using the NPCD also reported better quality of life outcomes, with significantly higher adherence to device use (96.6%) compared to the APCD (58.3%), indicating that the NPCD is not only more effective but also more user-friendly for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Nonpneumatic Active Compression Device in Older Adults with Breast Cancer-Related Lymphedema: A Subanalysis of a Randomized Crossover Trial. Rockson, SG., Skoracki, R.[2023]

In a study involving 36 patients with arm lymphedema after breast cancer treatment, the advanced pneumatic compression device (APCD) led to a significant 29% reduction in arm edema, while the standard device (SPCD) resulted in a 16% increase in edema over 12 weeks.

The APCD also showed a 5.8% reduction in tissue water, indicating better efficacy in managing lymphedema compared to the SPCD, which had a 1.9% increase in tissue water.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. Fife, CE., Davey, S., Maus, EA., et al.[2021]

A novel non-pneumatic compression device (NPCD) significantly reduced limb swelling by an average of 39.4% in patients with lower extremity lymphedema over a 12-week pilot study involving 24 participants.

The NPCD also improved overall quality of life, as measured by the Lymphedema Quality of Life Questionnaire, with significant enhancements in function, appearance, and mood, allowing patients to remain active during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-randomized, open-label study of the safety and effectiveness of a novel non-pneumatic compression device (NPCD) for lower limb lymphedema. Rockson, SG., Karaca-Mandic, P., Nguyen, M., et al.[2023]

A pilot study involving 40 subjects demonstrated that the Dayspring™ wearable compression system significantly improved quality of life (QoL) by 18% after 28 days of use, indicating its effectiveness in managing lymphedema.

The Dayspring device is user-friendly and allows for mobility during treatment, which may enhance adherence compared to traditional bulky pneumatic compression pumps, making it a promising alternative for lymphedema management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, an Open-Label Controlled Study. Rockson, SG., Karaca-Mandic, P., Skoracki, R., et al.[2022]

A 3-year study involving 18 patients with unilateral leg lymphedema demonstrated that high-pressure, long-duration pneumatic compression therapy significantly reduced limb circumference and improved tissue elasticity without any observed complications.

The therapy effectively compensates for the loss of lymphatic function by promoting fluid movement from swollen areas to regions with normal lymphatic drainage, making it a safe and effective treatment option for patients with lower limb lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of intermittent pneumatic compression in long-term therapy of lymphedema of lower limbs. Zaleska, M., Olszewski, WL., Durlik, M.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11764854/

Results from a comparative study to evaluate the treatment ... The NPCD was more effective than an APCD and resulted in superior limb volume decrease, greater improved quality of life, adherence, mobility, and patient ...

2. koyamedical.com koyamedical.com/healthcare-professionals/studies

Dayspring Publications, Clinical Research, and Other Studies Effectiveness of a Non-pneumatic Active Compression Device in Older Adults with Breast Cancer-Related Lymphedema: A Subanalysis of a Randomized Crossover Trial.

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/koyas-npcd-device-proves-more-effective-than-apcds-in-lymphedema/

Koya's NPCD device proves more effective than APCDs in ... Patients using the Dayspring system saw a greater reduction in limb volume and experienced improved quality of life compared to APCDs.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06418282

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

5. evtoday.com evtoday.com/news/koya-medical-dayspring-compression-device-evaluated-in-teays-study-for-lower-extremity-lymphedema

Koya Medical Dayspring Compression Device Evaluated in ... The data highlight superior efficacy and improved quality of life for patients treated with the Dayspring compared to APCDs.

6. koyamedical.com koyamedical.com/news-press-releases/koya-medical-announces-two-clinical-data-publications-for-dayspring-r-active-compression-treatments-for-lymphedema-and-venous-disease

Koya Medical Announces Dayspring Clinical Data ... Koya Medical announces two clinical data publications for Dayspring active compression treatments for lymphedema and venous disease.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9385615/

A non-randomized, open-label study of the safety and ... The Dayspring® non-pneumatic compression device (NPCD) is an FDA-cleared prescription-only wearable compression system (Fig. 1) that allows ...

8. jvsvenous.org jvsvenous.org/article/S2213-333X(22)00338-9/fulltext

Safety and effectiveness of a novel nonpneumatic active ... The results have shown that the novel NPCD is an effective maintenance treatment for reducing the limb volume in patients with breast cancer-related lymphedema.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06418282

NCT06418282 | Clinical Study to Evaluate the ... The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure ...

10. koyamedical.com koyamedical.com/patients/resources/dayspring-support

Support for Dayspring Compression Dayspring has been evaluated in over 11 clinical studies, including randomized controlled trials, demonstrating its safety, efficacy and clinical superiority.