Blood and Lymph Conditions

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Lymphedema

Breast Neoplasms

Breast Cancer Lymphedema

Unilateral Breast Neoplasms

Breast Diseases

Skin Diseases

Lymphatic Diseases

Postoperative Complications

Flexitouch Plus full arm and core treatment

Flexitouch Plus

Flexitouch Plus full arm and trunk/chest treatment

Flexitouch Plus FT with software modification

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.

A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients

A Feasibility Study Evaluating Flexitouch® Plus With a Therapy Cycle Software Modification in Patients With Unilateral Breast Cancer-Related Lymphedema (BCRL)

Comparison of the change in the rate of lymphatic propulsion events from the pre-treatment values to the post-treatment values for both the affected and contralateral limbs using the investigational technique of near infrared-fluorescent (NIRF) imaging.

Comparison of the percent change in local tissue water from the pre-treatment values to the post-treatment values on the affected limb using MoistureMeterD.

Swelling in the affected and contralateral limb as assessed using local tissue water content

Skin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).

Adverse events reported between treatment and the 24-hour follow-up

Comparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging.

Comparison of the change in dermal backflow from the pre-treatment values to the post-treatment values as the sum of the volume of area for all locations for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging

Compare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner)

Comparison of the percent of participants by arm demonstrating a decrease in thickness for each site, separating skin and subcutaneous changes, on the affected limb via Ultrasound

Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).

Tactile Medical

Flexitouch Plus: Flexitouch Plus full arm and core treatment

Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment

Flexitouch Plus With SW

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Michelle Wetherby

Affected Limb

Contralateral Limb

Lymphatic Activation

Changes in Swelling - MoistureMeterD

Changes in Swelling - Perometry

Affected Limb Percent Change

Contralateral Limb Percent Change

Percent Change in Skin Thickness From Baseline to After Treatment.

Incidence of Adverse Events

Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging

Affected Limb (Lateral Lower)

Contralateral Limb (Lateral Lower)

Affected Limb (Medial Lower)

Contralateral Limb (Medial Lower)

Affected Limb (Medial Upper)

Contralateral Limb (Medial Upper)

Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging

Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)

Skin Thickness (Site A)

Skin Thickness (Site B)

Skin Thickness (Site C)

Subcutaneous Thickness (Site A)

Subcutaneous Thickness (Site B)

Subcutaneous Thickness (Site C)

Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)

Affected Limb Absolute Change

Contralateral Limb Absolute Change

Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment.

Spots Global Cancer Trial Database for A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial