Actively Recruiting
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
Led by Koya Medical, Inc. · Updated on 2021-05-20
20
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females 63 18 years of age
- Willing to sign the informed consent and be able to follow the study protocol
- Diagnosis of upper extremity edema and have had or will undergo lymphatic surgery with Dr. Nguyen
- Difference in volume greater than 3% between the limbs
You will not qualify if you...
- History or presence of any systemic disorder that increases risk from compression therapy
- Unable or unwilling to participate in the study or provide informed consent
- Conditions preventing safe use of the device (cellulitis, open or healing wounds)
- Active or recurrent cancer or less than 3 months since completion of cancer treatment
- Diagnosed cognitive or physical impairment interfering with device use
- Diagnosis of lipedema
- Acute infection not treated for at least 2 weeks
- Acute thrombophlebitis in last 2 months
- Pulmonary embolism or deep vein thrombosis within 6 months
- Pulmonary edema
- Uncontrolled congestive heart failure
- Chronic kidney disease
- Epilepsy
- Poorly controlled asthma
- Pregnant, planning pregnancy, or nursing at study entry
- Participation in another clinical trial of an investigational substance or device within 30 days
- Bilateral limb edema
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dung Nguyen, MD, PharmD
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
D
Dung Nguyen, MD, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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