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
Koya Medical, Inc.
Summary
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
Description
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 proto…
Interventions
- DeviceDayspring Active Wearable Compression System
Dayspring Active Wearable Compression System
Location
- Dung Nguyen, MD, PharmDPalo Alto, California