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

NCT04888975 | Recruiting FDA Device

• 1 other identifier: KCT 005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphedema; Lymphedema, Breast Cancer; Lymphedema Arm

Outcome Measures

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.

  Baseline and at Day 28

Study Arms (1)

Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery

EXPERIMENTAL

Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery

Device: Dayspring Active Wearable Compression System

Interventions

Dayspring Active Wearable Compression System DEVICE

Dayspring Active Wearable Compression System

Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Koya Medical, Inc.: lead

Study Sites (1)

Dung Nguyen, MD, PharmD

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Lymphedema; Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dung Nguyen, MD, PharmD

CONTACT

4158510337; info@koyamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)