An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
NPCD
Glenn Jacobowitz
New York, New York, United States
RECRUITINGCost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
Time frame: 6 months
Mobility (daily steps using a pedometer)
Mobility (daily steps using a pedometer)
Time frame: 6 months
Venous Clinical Severity Score (VCSS)
Venous Clinical Severity Score (VCSS)
Time frame: 180 days
Lower extremity edema response (limb girth reduction)
Lower extremity edema response (limb girth reduction)
Time frame: 6 months
Safety/Adverse Events
As assessed by reported adverse events
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.