NCT04888975 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
| NCT ID | NCT04888975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Koya Medical, Inc. |
| Condition | Lymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2021-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2021-06-01 with a primary completion date of 2021-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04888975 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04888975 currently recruiting?
Yes, NCT04888975 is actively recruiting participants. Contact the research team at info@koyamedical.com for enrollment information.
Where is the NCT04888975 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT04888975 clinical trial?
NCT04888975 is sponsored by Koya Medical, Inc.. The trial plans to enroll 20 participants.