A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients With Breast Cancer Related Lymphedema (BCRL) After Lymphatic Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKoya Medical, Inc.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Dayspring Active Wearable Compression System

    Device

    Dayspring Active Wearable Compression System

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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