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

Sponsored by Koya Medical, Inc.

About this trial

Last updated 2 years ago

Study ID

KCT 006

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial 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

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status