A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Phase: NA
Conditions: Lymphedema, Lymphedema Lower Extremity, Chronic Venous Insufficiency, Secondary Lymphedema
Sponsor: Koya Medical, Inc.

OƯicial Title 
A non-randomized, open-label study to evaluate the safety and eƯectiveness 
of Koya active wearable compression technology for treating lower limb 
lymphedema 
 
NCT Number: NCT04897035 
Protocol Number: KCT 006 
Document Date: 01/01/2021 

 
 
Study Title
A non-randomized, open-label study to evaluate the safety and effectiveness 
of Koya active wearable compression technology for treating lower limb 
lymphedema 
Study Objective
To demonstrate that the Koya active wearable compression technology is 
safe and effective for use 
Clinical 
Hypothesis 
1. The Koya wearable device improves quality of life (LYMQOL®) in subjects 
with lower extremity edema as measured by the difference between pre-
use and post-use of the device 
2. The Koya wearable device is safe for use as assessed by adverse events 
3. The Koya active wearable compression device maintains or reduces 
swelling in patients with lower extremity edema as measured by the 
difference between pre-use and post-use of the device 
Subject 
Population 
Up to 50 subjects will be enrolled.
Investigational 
Materials 
● The Koya wearable device is a smart calibrated active gradient pressure 
full-leg 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. These patterns are similar to advanced 
pneumatic compression devices, which are known to produce safe, well-
regulated compression.  
● A controller with a rechargeable battery that powers the limb garment 
Study Design
Structure 
Non-randomized, open-label pilot study
Number of Sites 
Up to six (6) sites.   
Duration
The duration of subject participation is approximately four (4) months 
Control 
None
Visit Schedule
Subjects will be seen at the screening visit, day 0, day 7, and week 4, week 8 
and week 12   
Clinical 
Parameters 
● LYMQOL Survey Index  
● Sequential Circumference using Tape Measure  
● Photography of the lower limb 
Primary Endpoints
● LYMQOL Index 
Secondary 
Endpoints 
● Lower Limb Volume 
● Adverse Event 
● Adherence (exploratory) 
Key Inclusion 
Criteria  
(not a complete 
list)  
● 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. 
 
Key Exclusion 
Criteria 
(not a complete  
list) 
● 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 
● 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 
● 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