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Dayspring Technology for Breast Cancer Related Lymphedema

This study is testing a device called the Dayspring Active Wearable Compression System. It's for people who have lymphedema (swelling caused by fluid buildup) in their arm after surgery for breast cancer. The study wants to see how safe and effective the Dayspring system is at helping lymph (fluid) move better. You might be able to join if you are 18 or older, have upper arm swelling, and have had or will have lymphatic surgery with Dr. Nguyen. Your arm swelling must also be more than 3% different from your other arm. The main way they will measure success is by looking at your lymph movement using a special imaging test at the beginning and again after 28 days.

Study design
This is an open-label study, meaning you and your doctors will know what treatment you are receiving. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your lymph movement will be checked at the start of the study and again after 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04888975

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

Recruiting
NAAges 18+InterventionalTreatment
Koya Medical, Inc.
~20 participants
Updated 2021-05-20 on ClinicalTrials.gov
What's tested:Dayspring Active Wearable Compression System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ICG Fluorescence Lymphatic Imaging
Measured over Baseline and at Day 28

Conditions

Lymphedema
Lymphedema, Breast Cancer
Lymphedema Arm

Explore related trials

Breast CarcinomaLymphedema

Where it's being run

1 sites across 1 states
California1

Who to contact

Dung Nguyen, MD, PharmD
[email protected]
4158510337
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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
Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
Diagnosis of lipedema
Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study
Diagnosis of acute thrombophlebitis (in last 2 months)
Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
Diagnosis of pulmonary edema
Diagnosis of congestive heart failure (uncontrolled)
Diagnosis of chronic kidney disease
Diagnosis of epilepsy
Patients with poorly controlled asthma
Women who are pregnant, planning a pregnancy or nursing at study entry
Participation in any clinical trial of an investigational substance or device during the past 30 days
Bilateral limb edema

What this trial measures

  • ICG Fluorescence Lymphatic ImagingBaseline and at Day 28

    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.