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

Not Applicable

• Conditions: Lymphedema, Breast Cancer; Lymphedema; Lymphedema Arm
• Interventions: Device: Dayspring Active Wearable Compression System

• Registration Number: NCT04888975
• Lead Sponsor: Koya Medical, Inc.

Brief Summary

To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

Detailed Description

To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-17
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20
• Study Start: 2021-06-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery	Dayspring Active Wearable Compression System	Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery

Primary Outcome Measures

Name	Time	Method
ICG Fluorescence Lymphatic Imaging	Baseline 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.

Trial Locations

Locations (1)

Dung Nguyen, MD, PharmD; 🇺🇸 Palo Alto, California, United States