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Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema

A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

NCT04897035•Koya Medical, Inc.

View on ClinicalTrials.gov

Summary

A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

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 primary or secondary unilateral lower extremity edema
•At the time of initial evaluation, individuals must be at least 3 months post surgery, chemotherapy and/or radiation treatment for cancer if applicable

Exclusion Criteria

•Individuals with a history or presence of an acute 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.)
•Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
•Diagnosis of lipedema
•Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
•Diagnosis of Acute infection (in the last four weeks)
•Diagnosis of acute thrombophlebitis (in last 6 months)
•Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
•Diagnosis of pulmonary edema
+7 more criteria

Locations (2)

PT works

Los Altos, California, United States

Ginger-K Lymphedema & Cancer Center

Morgan Hill, California, United States

Key Dates

Start Date

June 1, 2021

Primary Completion Date

June 30, 2022

Completion Date

July 1, 2022

Last Updated

February 17, 2026

Enrollment

ACTUAL participants

Conditions

LymphedemaLymphedema Lower ExtremityChronic Venous InsufficiencySecondary Lymphedema

Interventions

Dayspring Active Wearable Compression System

DEVICE

The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression

NCT07449728

Varicose VeinsChronic Venous Insufficiency

View study

RECRUITING

Vascular Lab Resource (VLR) Biorepository

NCT05628948

Cardiovascular DiseasesMetabolic Disease+14 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: February 17, 2026Data 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.

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Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema

Inclusion Criteria

Exclusion Criteria

The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression

Vascular Lab Resource (VLR) Biorepository

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