About this trial
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females ≥ 18 years of age
Willing to sign the informed consent and deemed capable of following the study protocol
Subjects must have a diagnosis of upper extremity edema and have or will undergo lymphatic surgery with Dr. Nguyen
Subjects must have a difference in volume greater than 3% between the limbs.
Disqualifiers
Individuals with a history or presence of a systemic disorder or condition that could place the patient at increased risk from sequential compression therapy
Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer
Trial design
Single group
Treatments tested in this trial
Dayspring Active Wearable Compression System
DeviceDayspring Active Wearable Compression System
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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