A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema
Completed · Not applicable
Conditions studied: Lymphedema, Lymphedema of Upper Arm, Lymphedema, Breast Cancer
In brief
To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)
Key facts
- Study ID
- NCT04908254
- Run by
- Koya Medical, Inc.
- People needed
- 50
- Starts
- 2021-06-01
- Expected to finish
- 2021-12-31
- Last updated by the study team
- 2025-12-09
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 upper extremity edema
You may not qualify if…
- Individuals with a history or presence of a systemic disorder or condition that could place the subject 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
- Subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
- Subjects 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 renal failure
- Diagnosis of epilepsy
- Subjects 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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