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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dayspring Active Wearable Compression Device | Experimental | 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. |
|
| Advanced Pneumatic Compression Device | Active Comparator | A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crossover Device (PCD or Dayspring - alternate to first group) | Device | Cross over arms after a month of use and a month of washout period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Safety/AEs | As assessed by reported adverse events | 1 month |
| Therapy adherence tracking | A table will be provided to patient to document days of use with the device to track adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PT works | Los Altos | California | 94024 | United States | ||
| Ginger-K Lymphedema & Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37729078 | Derived | Rockson SG, Skoracki R. Effectiveness of a Nonpneumatic Active Compression Device in Older Adults with Breast Cancer-Related Lymphedema: A Subanalysis of a Randomized Crossover Trial. Lymphat Res Biol. 2023 Dec;21(6):581-584. doi: 10.1089/lrb.2022.0085. Epub 2023 Sep 20. | |
| 35952956 | Derived | Rockson SG, Whitworth PW, Cooper A, Kania S, Karnofel H, Nguyen M, Shadduck K, Gingerich P, Armer J. Safety and effectiveness of a novel nonpneumatic active compression device for treating breast cancer-related lymphedema: A multicenter randomized, crossover trial (NILE). J Vasc Surg Venous Lymphat Disord. 2022 Nov;10(6):1359-1366.e1. doi: 10.1016/j.jvsv.2022.06.016. Epub 2022 Aug 8. |
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Single Crossover
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| 1 month |
| Patient survey on preference | A study survey administered at the end of the study to measure patient preference between the two devices | 1 month |
| Morgan Hill |
| California |
| 95037 |
| United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2026 | Apr 14, 2026 | 2 | ||
| Apr 15, 2026 | May 4, 2026 | 3 |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D000072656 | Breast Cancer Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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