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A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema | Clinical Trials | Clareo Health

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A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema

A Multi-center Randomized Control Cross-over Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema (TEAYS)

NCT05507346•Koya Medical, Inc.

View on ClinicalTrials.gov

Summary

To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)

Detailed Description

A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring, a Novel Portable Non-Pneumatic Active Compression Device (NPCD) vs. an Advanced Pneumatic Compression Device (APCD) for Treating Lower Extremity Lymphedema. To evaluate the Dayspring, a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females ≥ 18 years of age
•Capable and willing to sign the informed consent and deemed capable of following the study protocol
•Subjects must have a diagnosis of primary or secondary unilateral or bilateral lower extremity edema or lower extremity phlebolymphedema from chronic venous insufficiency

Exclusion Criteria

•Individuals with a history or presence of a systemic disorder or condition that could place the subject 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
•Subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
•Subjects must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
•Individuals who present with Ankle-brachial Index (ABI) screening score \< 0.8 and \> 1.30, indicating the possibility of Peripheral Arterial disease (PAD)
•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
+8 more criteria

Locations (1)

Stanley G Rockson

Oakland, California, United States

Key Dates

Start Date

September 6, 2022

Primary Completion Date

January 9, 2024

Completion Date

January 9, 2024

Last Updated

December 12, 2025

Enrollment

121

ACTUAL participants

Conditions

LymphedemaLymphedema of LegChronic Venous InsufficiencyVenous InsufficiencyLymphedema, Lower Limb

Interventions

Cross over Device (PCD or Dayspring - alternate to first group)

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: December 12, 2025Data 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 Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema

Inclusion Criteria

Exclusion Criteria

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

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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