RecruitingNot ApplicableNCT04888975
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
Sponsor
Koya Medical, Inc.
Enrollment
20 participants
Start Date
Jun 1, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is evaluating a device called Dayspring Technology — a type of compression therapy — in women who have arm swelling (lymphedema) after breast cancer surgery. Researchers want to see if this device is safe and effective when used after lymphatic surgery.
**You may be eligible if...**
- You are 18 or older
- You have been diagnosed with upper arm lymphedema (swelling) following breast cancer treatment
- You have had or will have lymphatic surgery with the study's designated surgeon
- There is a measurable volume difference of more than 3% between your arms
**You may NOT be eligible if...**
- You have active or recurring cancer, or completed chemotherapy, radiation, or primary surgery less than 3 months ago
- You have an open wound, active skin infection, or conditions that prevent safe device use
- You have a blood clot history (DVT or pulmonary embolism) in the past 6 months
- You have congestive heart failure, chronic kidney disease, epilepsy, or pulmonary edema
- You are pregnant or planning to become pregnant
- You have swelling in both arms
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DEVICEDayspring Active Wearable Compression System
Dayspring Active Wearable Compression System
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04888975
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