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

Koya Medical

Status

Completed

Conditions

Lymphedema Lower Extremity

Secondary Lymphedema

Lymphedema

Chronic Venous Insufficiency

Treatments

Device: Dayspring Active Wearable Compression System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04897035

KCT 006

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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