Portable Compression Device for Lymphedema

(GRANDE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Koya Medical, Inc.

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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

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 data supports the idea that Portable Compression Device for Lymphedema is an effective treatment?

The available research shows that the Portable Compression Device for Lymphedema, also known as the Non-Pneumatic Compression Device (NPCD), is effective in reducing swelling and improving quality of life for patients. In a study comparing NPCD to a traditional pneumatic device, older adults experienced a significant decrease in limb swelling and better quality of life scores with NPCD. Another study found that NPCD allowed patients to stay active during treatment and led to significant improvements in quality of life and limb swelling. Compared to traditional devices, NPCD also had higher adherence rates, meaning patients were more likely to use it consistently. ^{1 2 3 4 5}

What safety data exists for the portable compression device for lymphedema?

The safety of the portable compression device, known as NPCD or Dayspring, has been evaluated in several studies. A multicenter randomized crossover trial (NILE) compared the NPCD with an advanced pneumatic compression device (APCD) and found it to be safe and effective for treating breast cancer-related lymphedema. A subanalysis of this trial in older adults showed superior clinical and quality-of-life outcomes with the NPCD. Another non-randomized, open-label study on lower limb lymphedema reported significant improvements in quality of life and limb edema with the NPCD. Additionally, an open-label controlled study of the Dayspring device demonstrated significant improvements in quality of life and limb volume, with high adherence rates, suggesting it is safe and effective for lymphedema treatment. ^{1 2 3 4 5}

Is the treatment NPCD a promising treatment for lymphedema?

Yes, the NPCD is a promising treatment for lymphedema. It allows patients to stay active during treatment, improves quality of life, and reduces swelling effectively. It is easy to use and has high adherence rates, making it a good alternative to traditional treatments that require immobility. ^{2 3 4 5 6}

Research Team

Eligibility Criteria

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 am 18 years old or older.

Exclusion Criteria

I cannot walk by myself.

My BMI is over 34.

I have been diagnosed with fluid in my lungs.

Treatment Details

Interventions

• NPCD (Compression Device)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Koya Medical, Inc.

Lead Sponsor

Trials

7

Recruited

430+

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. [2021]

2. United States 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). [2022]

3. United States 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. [2023]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, an Open-Label Controlled Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of intermittent pneumatic compression in long-term therapy of lymphedema of lower limbs. [2021]