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
Last Updated: 2021-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-06-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery
Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery
Dayspring Active Wearable Compression System
Dayspring Active Wearable Compression System
Interventions
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Dayspring Active Wearable Compression System
Dayspring Active Wearable Compression System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Koya Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Dung Nguyen, MD, PharmD
Palo Alto, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KCT 005
Identifier Type: -
Identifier Source: org_study_id
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