Dayspring wearable compression for breast cancer–related arm lymphedema after lymphatic surgery
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients With Breast Cancer Related Lymphedema (BCRL) After Lymphatic Surgery
NA · Koya Medical, Inc. · NCT04888975
This study will test whether the Dayspring wearable compression system helps move lymph and reduce arm swelling in adults with breast cancer–related lymphedema after lymphatic surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Koya Medical, Inc. (industry) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT04888975 on ClinicalTrials.gov |
What this trial studies
This is a non-randomized, open-label trial of the Dayspring Active Wearable Compression System used after lymphatic surgery to promote lymph movement and reduce upper-extremity swelling. Adult participants with breast cancer–related arm lymphedema and a limb volume difference greater than 3% will wear the device and be followed for safety and effectiveness outcomes. The study is sponsored by Koya Medical and conducted at a single site with Dr. Dung Nguyen in Palo Alto, California. Outcomes will focus on limb volume changes, device tolerability, and any device-related adverse events.
Who should consider this trial
Good fit: Adults aged 18 or older with breast cancer–related upper-extremity lymphedema who have had or will undergo lymphatic surgery with Dr. Nguyen and who have a limb volume difference greater than 3% are ideal candidates.
Not a fit: Patients with active or recurrent cancer within three months of cancer therapy, those with conditions that make sequential compression unsafe, or those with open wounds or cellulitis are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could reduce arm swelling and improve comfort and mobility after lymphatic surgery.
How similar studies have performed: Other wearable and pneumatic compression approaches have shown benefits for lymphedema in prior studies, but the Dayspring system is a newer device with limited published data specific to its use after lymphatic surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females ≥ 18 years of age * Willing to sign the informed consent and deemed capable of following the study protocol * Subjects must have a diagnosis of upper extremity edema and have or will undergo lymphatic surgery with Dr. Nguyen * Subjects must have a difference in volume greater than 3% between the limbs. Exclusion Criteria: * Individuals with a history or presence of a systemic disorder or condition that could place the patient at increased risk from sequential compression therapy * Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent * Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.) * Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer * Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device * Diagnosis of lipedema * Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study * 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) * Diagnosis of chronic kidney disease * Diagnosis of epilepsy * Patients with poorly controlled asthma * 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 * Bilateral limb edema
Where this trial is running
Palo Alto, California
- Dung Nguyen, MD, PharmD — Palo Alto, California, United States (RECRUITING)
Study contacts
- Study coordinator: Dung Nguyen, MD, PharmD
- Email: info@koyamedical.com
- Phone: 4158510337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphedema, Lymphedema, Breast Cancer, Lymphedema Arm