A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compressi… (NCT05507346) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
United States121 participantsStarted 2022-09-06
Plain-language summary
To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion Criteria:
* Males and females ≥ 18 years of age
* Capable and willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must have a diagnosis of primary or secondary unilateral or bilateral lower extremity edema or lower extremity phlebolymphedema from chronic venous insufficiency
Exclusion Criteria:
* 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
* Individuals who present with Ankle-brachial Index (ABI) screening score \< 0.8 and \> 1.30, indicating the possibility of Peripheral Arterial disease (PAD)
* 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 (uncontrolle…