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To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery | Experimental | Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dayspring Active Wearable Compression System | Device | Dayspring Active Wearable Compression System |
|
| Measure | Description | Time Frame |
|---|---|---|
| ICG Fluorescence Lymphatic Imaging | ICG fluorescence lymphatic imaging evaluates for changes in lymphatic drainage of the limb. ICG is a water soluble tricarbocyanine dye, has a short plasma half life of 3 to 5 minutes in humans, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. ICG contains sodium iodide and is recommended by manufacturer to be used with caution in patients who have a history of allergy to iodides, although type-I allergic reaction (anaphylaxis) cannot really occur because iodine is a chemical element that is an essential component of the human body. | Baseline and at Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dung Nguyen, MD, PharmD | Contact | 4158510337 | info@koyamedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dung Nguyen, MD, PharmD | Recruiting | Palo Alto | California | 94304 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 5, 2025 | Dec 19, 2025 | 2 | ||
| Mar 27, 2026 | Apr 15, 2026 | 3 | ||
| Apr 15, 2026 | May 5, 2026 | 4 |
| 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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