Stopped: Due to unforeseen slow enrollment and a shift in corporate resources due to the COVID-19 impact.
The objective of the study is to demonstrate equivalency in treatment effect, as determined by objective measurements, between the modified therapy cycle software and the FDA-cleared Flexitouch therapy cycle software.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Lymphatic Activation
Timeframe: Baseline and following a single treatment, an average of one hour
Changes in Swelling - MoistureMeterD
Timeframe: Baseline and following a single treatment, an average of one hour
Changes in Swelling - Perometry
Timeframe: Baseline and following a single treatment, an average of one hour
Percent Change in Skin Thickness From Baseline to After Treatment.
Timeframe: Baseline and following a single treatment, an average of one hour
Incidence of Adverse Events
Timeframe: 24-Hour Follow-Up
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
Timeframe: Baseline and following a single treatment, an average of one hour
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
Timeframe: Baseline and following a single treatment, an average of one hour
Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)
Timeframe: Baseline and following a single treatment, an average of one hour
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Timeframe: Baseline and following a single treatment, an average of one hour
Absolute Change in Skin Thickness From Baseline to After Treatment
Timeframe: Baseline and following a single treatment, an average of one hour.