Dayspring wearable compression for breast cancer–related arm lymphedema after lymphatic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Dung Nguyen, MD, PharmD
  Palo Alto, California, United States Recruiting

Study contacts

• Study coordinator: Dung Nguyen, MD, PharmD
• Email: info@koyamedical.com
• Phone: 4158510337

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.