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 join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Wearing a device
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery"
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether the Dayspring wearable compression device safely helps move lymph fluid after lymphatic surgery. It is for adults with arm swelling linked to breast cancer.
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older.
- Willing to sign a form agreeing to join and able to follow study rules.
- Have arm swelling and have had or will have lymphatic surgery with Dr. Nguyen.
- Have more than a 3% difference in size between the arms.
Who can't join
- A health condition that makes compression treatment risky; skin infection, open wounds, or healing wounds that prevent safe device use.
- Cannot or will not follow all study rules or give consent; thinking or physical problems that prevent device use.
- Active cancer or cancer that has returned; finished chemotherapy, radiation, or main cancer surgery less than 3 months before the first evaluation.
- Lipedema (abnormal fat buildup) or swelling in both arms; a current infection whose source has not been treated for 2 weeks before joining.
- An inflamed vein with a blood clot in the past 2 months; a blood clot in a deep vein or lung in the past 6 months.
- Fluid in the lungs, uncontrolled heart failure, long-term kidney disease, epilepsy (a seizure disorder), or poorly controlled asthma.
- Pregnant, planning a pregnancy, or breastfeeding when joining.
- Took part in a trial of an experimental substance or device in the past 30 days.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
CA
- Dung Nguyen, MD, PharmD · Palo Alto, CA 94304Dung Nguyen, MD, PharmD · Study contact · 415-851-0337 · info@koyamedical.comMore trials in Palo Alto