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

NCT04897035 | Completed Results FDA Device

• 1 other identifier: KCT 006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• LYMQOL (LYMphedema Quality of Life) ***All Relevant Time Points Used in the Calculation in the Time Frame (e.g., Baseline and 3 Months).***

  The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, was also administered at baseline and at month 3. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 3. Higher value is better on the QoL outcome and is more favorable.

  3 months

• Change in Edema Volume

  Change in edema volume is measured as the difference between the edema volume at 3 months and edema volume at baseline. Edema volume is the difference in volume between the affected and unaffected limb. Limb volume measurement is performed by using a calibrated tape measure to measure circumference from the ankle and at 4cm increments to the waist region. Measurements are taken for both lower extremities. Volume is calculated based on cylindrical segment analysis. A greater change in edema volume between the two time points is better on reduction of limb volume/swelling.

  3 months

Secondary Outcomes (2)

• Safety/AEs

  3 months

• Number of Patients Using the Device Every Day for at Least 45 Minutes

  3 months

Study Arms (1)

Subjects with Lower Extremity Lymphedema and phlebolymphedema

EXPERIMENTAL

Lower Extremity Lymphedema and phlebolymphedema

Device: Dayspring Active Wearable Compression System

Interventions

Dayspring Active Wearable Compression System DEVICE

Dayspring Active Wearable Compression System

Subjects with Lower Extremity Lymphedema and phlebolymphedema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koya Medical, Inc.: lead

Study Sites (2)

PT works

Los Altos, California, 94024, United States

Location

Ginger-K Lymphedema & Cancer Center

Morgan Hill, California, 95037, United States

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Koya Medical

clinical@koyamedical.com

4158510337

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 21, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 1, 2022
• Last Updated: February 17, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)