Actively Recruiting
Safety and Effectiveness Study of the Dayspring Active Wearable Compression System for Breast Cancer-Related Lymphedema After Lymphatic Surgery
Led by Koya Medical, Inc. · Updated on 2021-05-20
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the Dayspring Active Wearable Compression Technology in improving lymph flow and to assess its safety and effectiveness in patients who have undergone lymphatic surgery for breast cancer-related lymphedema (BCRL). The study focuses on adults diagnosed with upper extremity edema after lymphatic surgery and investigates how this device may help manage symptoms associated with BCRL. Participants will use the Dayspring Active Wearable Compression System, a device designed to enhance lymph movement following lymphatic surgery. The study is open-label and non-randomized, involving patients with breast cancer-related lymphedema who meet specific volume difference criteria between limbs. The intervention period includes baseline assessments and follow-up evaluations at 28 days. During the study, participants will undergo ICG Fluorescence Lymphatic Imaging both at the start and on day 28 to measure lymphatic function. Researchers will monitor safety and effectiveness through these imaging assessments and track participant adherence to device use. The total participation duration includes initial and follow-up visits within the 28-day study period.
CONDITIONS
Brief 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 18 years of age or older
- Willing to sign informed consent and able to follow the study protocol
- Diagnosis of upper extremity edema and have had or will have lymphatic surgery with Dr. Nguyen
- Limb volume difference greater than 3% between arms
You will not qualify if you...
- History or presence of systemic disorders increasing risk from compression therapy
- Unable or unwilling to participate fully or provide informed consent
- Presence of cellulitis, open wounds, or healing wounds preventing safe device use
- Active or recurrent cancer, or less than 3 months since completing chemotherapy, radiation, or surgery for cancer
- Cognitive or physical impairments interfering with device use
- Diagnosis of lipedema
- Acute infection untreated for at least 2 weeks
- Acute thrombophlebitis within last 2 months
- Pulmonary embolism or deep vein thrombosis within previous 6 months
- Pulmonary edema
- Uncontrolled congestive heart failure
- Chronic kidney disease
- Epilepsy
- Poorly controlled asthma
- Women who are pregnant, planning pregnancy, or nursing
- Participation in another clinical trial of investigational substance or device within past 30 days
- Bilateral limb edema
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants use the Dayspring Active Wearable Compression System after lymphatic surgery to enhance lymph movement and assess its safety and effectiveness.
2 visits (baseline and Day 28)
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
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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