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

NCT ID: NCT04897035

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-07-01

Brief 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

Conditions

Lymphedema; Lymphedema Lower Extremity; Chronic Venous Insufficiency; Secondary Lymphedema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects with Lower Extremity Lymphedema and phlebolymphedema

Lower Extremity Lymphedema and phlebolymphedema

Group Type: EXPERIMENTAL

Dayspring Active Wearable Compression System

Intervention Type: DEVICE

Dayspring Active Wearable Compression System

Interventions

Dayspring Active Wearable Compression System

Dayspring Active Wearable Compression System

Intervention Type: DEVICE

Eligibility Criteria

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
• Diagnosis of congestive heart failure (uncontrolled)
• Diagnosis of chronic kidney disease with acute renal failure
• Diagnosis of epilepsy
• Patients 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
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Koya Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PT works

Los Altos, California, United States

Ginger-K Lymphedema & Cancer Center

Morgan Hill, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

KCT 006

Identifier Type: -

Identifier Source: org_study_id