Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema

Completed · Not applicable

Conditions studied: Lymphedema, Lymphedema Lower Extremity, Chronic Venous Insufficiency, Secondary Lymphedema

In brief

A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

Key facts

Study ID

NCT04897035

Run by

Koya Medical, Inc.

People needed

24

Starts

2021-06-01

Expected to finish

2022-07-01

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 primary or secondary unilateral lower extremity edema
• At the time of initial evaluation, individuals must be at least 3 months post surgery, chemotherapy and/or radiation treatment for cancer if applicable

You may not qualify if…

• Individuals with a history or presence of an acute 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.)
• Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
• 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 acute thrombophlebitis (in last 6 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 with acute renal failure
• Diagnosis of epilepsy
• Patients 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

Where it is running

• PT works — Los Altos, California, United States
• Ginger-K Lymphedema & Cancer Center — Morgan Hill, California, United States

Full record on ClinicalTrials.gov

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