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Tests treatment safety and results for Lymphedema
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
ClinicalTrials.gov ID: NCT04888975
What this study is testing
- What it's testing
- To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Males and females ≥ 18 years of age
- Willing to sign the informed consent and deemed capable of following the study protocol
- people must have a diagnosis of upper extremity edema and have or will undergo lymphatic surgery with Dr. Nguyen
- people must have a difference in volume greater than 3% between the limbs.
You likely can't join if
- Individuals with a history or presence of a systemic disorder or condition that could place the patient at increased risk from sequential compression...
- 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...
- Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
- Diagnosis of lipedema
See the full eligibility criteria
- Males and females ≥ 18 years of age
- Willing to sign the informed consent and deemed capable of following the study protocol
- people must have a diagnosis of upper extremity edema and have or will undergo lymphatic surgery with Dr. Nguyen
- people must have a difference in volume greater than 3% between the limbs.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.