Clinical trial NCT04897035: A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Official title: A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Lymphedema Lower Extremity
Chronic Venous Insufficiency
Secondary Lymphedema
Lead sponsor: Koya Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

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

Primary outcomes:
measure: LYMQOL (LYMphedema Quality of Life)
timeFrame: 3 months
measure: Limb Volume Maintenance or Improvement
timeFrame: 3 months
Secondary outcomes:
measure: Safety/AEs
timeFrame: 3 months
measure: Therapy adherence tracking
timeFrame: 3 months
measure: Patient survey
timeFrame: 3 months
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: PT works
state: California
city: Morgan Hill
country: United States
facility: Ginger-K Lymphedema & Cancer Center
state: California
Study officials:
References: