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

NCT ID: NCT05507346

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2024-01-09

Brief 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.

Conditions

Lymphedema; Lymphedema of Leg; Chronic Venous Insufficiency; Venous Insufficiency; Lymphedema, Lower Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dayspring, Non-Pneumatic Active Compression Device (NPCD)

The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Cross over after three month of use and a month of washout period

Advanced Pneumatic Compression Device (APCD)

A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Cross over after three month of use and a month of washout period

Interventions

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

Cross over after three month of use and a month of washout period

Intervention Type: DEVICE

Eligibility Criteria

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
• Diagnosis of pulmonary edema
• Diagnosis of congestive heart failure (uncontrolled/uncompensated)
• Diagnosis of chronic kidney disease with acute renal failure
• Diagnosis of epilepsy
• Subjects with poorly controlled asthma
• Any condition where increased venous and lymphatic return is undesirable
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Koya Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanley G Rockson

Oakland, California, United States

Countries

United States

Other Identifiers

KCT 009 (TEAYS)

Identifier Type: -

Identifier Source: org_study_id