An interventional study of Crossover Device (PCD or Dayspring - alternate to first group) in Lymphedema, Lymphedema of Upper Arm and Lymphedema, Breast Cancer, sponsored by Koya Medical, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Koya Medical, Inc. · Not applicable, Interventional, and Treatment
To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)
A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema. To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.
560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 403 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Koya Medical, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The Dayspring Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure full-arm 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.
Device: Crossover Device (PCD or Dayspring - alternate to first group)
A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.
Device: Crossover Device (PCD or Dayspring - alternate to first group)
Cross over arms after a month of use and a month of washout period
Arm Volume Maintenance or Improvement
Limb volume measurement is performed by using a calibrated tape measure to measure circumference from the wrist and the ulnar styloid process and at 4cm increments to the axilla. Measurements to be taken for both upper extremities. Volume is calculated based on cylindrical segment analysis. The outcome measure is assessed as a difference or change from baseline to month 1
Time frame: 1 month
LYMQOL (LYMphedema Quality of Life)
The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 1. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 1
Time frame: 1 month
Safety/AEs
As assessed by reported adverse events
Time frame: 1 month
Therapy adherence tracking
A table will be provided to patient to document days of use with the device to track adherence
Time frame: 1 month
Patient survey on preference
A study survey administered at the end of the study to measure patient preference between the two devices
Time frame: 1 month
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Koya Medical, Inc.