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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 | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT04888975•Koya Medical, Inc.

View on ClinicalTrials.gov

Summary

To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

Detailed Description

To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (1)

Dung Nguyen, MD, PharmD

Palo Alto, California, United States

Key Dates

Start Date

June 1, 2021

Primary Completion Date

December 31, 2021

Completion Date

December 31, 2021

Last Updated

May 20, 2021

Enrollment

ESTIMATED participants

Conditions

LymphedemaLymphedema, Breast CancerLymphedema Arm

Interventions

Dayspring Active Wearable Compression System

DEVICE

Contacts

Dung Nguyen, MD, PharmD

CONTACT

4158510337 info@koyamedical.com

Vascular Lab Resource (VLR) Biorepository

NCT05628948

Cardiovascular DiseasesMetabolic Disease+14 more

View study

RECRUITINGNA

Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

NCT06418282

PhlebolymphedemaLymphedema+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Vascular Lab Resource (VLR) Biorepository

Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

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