NCT04888975 · Koya Medical, Inc.
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
(TIGRIS)
What this study is about
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
View original scientific description
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Palo Alto, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2021 · Source of record for eligibility and locations