An interventional study of Dayspring Active Wearable Compression System in Lymphedema, Lymphedema, Breast Cancer and Lymphedema Arm, sponsored by Koya Medical, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Koya Medical, Inc. · Not applicable, Interventional, and Treatment
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
569 studies on the registry are indexed under Lymphedema; 136 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 407 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Koya Medical, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery
Device: Dayspring Active Wearable Compression System
Dayspring Active Wearable Compression System
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.
Time frame: Baseline and at Day 28
Plan to share: No
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Koya Medical, Inc.