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

RECRUITINGNA

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

An Open-label, Multi-center, Prospective VA Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

NCT06418282•Koya Medical, Inc.

View on ClinicalTrials.gov

Summary

An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema

Detailed Description

An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema

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 unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency
•Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux

Exclusion Criteria

•Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
•Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
•Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device
•Non-ambulatory individuals
•Female: BMI \> 34 (5'4", 200 lbs.)
•Male: BMI \> 34 (5'9", 230 lbs.)
•(Max circumference at patella 58 cm; Max circumference at gluteal fold 75 cm)
•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)
+11 more criteria

Locations (1)

Glenn Jacobowitz

New York, New York, United States

Key Dates

Start Date

May 13, 2024

Primary Completion Date

December 31, 2025

Completion Date

January 31, 2026

Last Updated

December 12, 2025

Enrollment

100

ESTIMATED participants

Conditions

PhlebolymphedemaLymphedemaChronic Venous Insufficiency

Interventions

Dayspring

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.

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

Inclusion Criteria

Exclusion Criteria

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

Vascular Lab Resource (VLR) Biorepository

Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over

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