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An open-label study to clinically assess a novel wearable advanced compression technology (Dayspringâ„¢) undertaken to determine if potential barriers to lymphedema self-care were effectively addressed. The Dayspringâ„¢ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system. The following endpoints are examined:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast-cancer related lymphedema (BCRL) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| User of Dayspring device | Device | The Dayspringâ„¢ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| LYMQOL (LYMphedema Quality of Life) | The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, was also administered at baseline and at day 28. Overall QoL is scored on a single item by the patient on a scale of 1-10. | 28 days |
| Arm Volume Maintenance or Improvement | Limb volume measurement was 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 were taken for both upper extremities. If both extremities exhibited edema, a study arm was designated for treatment. Measurements were taken by the same investigator throughout the study. Volume was calculated based on cylindrical segment analysis. | 28 days |
| Safety/AEs | As assessed by reported adverse events | 28 days |
| Therapy adherence tracking | Therapy adherence tracked via the mobile app linked to the Dayspringâ„¢ device. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient survey | A visual analog scale (VAS) and study survey were administered at the end of the study to measure patient satisfaction (day 28). The six-item questionnaire was used to document the time of day the device was used, if daily activities were supported during use, function, and symptoms. All were measured on a scale from 1-5. The VAS was administered to previous users of pneumatic compression devices to assess preference and likelihood to recommend to others with lymphedema. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley G Rockson, MD | Medical Advisor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PT works | Los Altos | California | 94024 | United States | ||
| Ginger-K Lymphedema & Cancer Center |
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| 28 days |
| Morgan Hill |
| California |
| 95037 |
| United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 5, 2025 | Dec 19, 2025 | 3 | ||
| Mar 27, 2026 | Apr 15, 2026 | 4 | ||
| Apr 15, 2026 | May 5, 2026 | 5 |
| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| D008209 | 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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