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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery 		Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery
  • Device: Dayspring Active Wearable Compression System
    Dayspring Active Wearable Compression System

Recruiting Locations

Dung Nguyen, MD, PharmD
Palo Alto, California 94304
Contact:
Dung Nguyen, MD, PharmD
415-851-0337
info@koyamedical.com

More Details

Status
Recruiting
Sponsor
Koya Medical, Inc.

Study Contact

Dung Nguyen, MD, PharmD
4158510337
info@koyamedical.com

Detailed Description

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