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

Not Applicable

Terminated

Conditions: Breast Cancer Related Lymphedema

Interventions: Device: Flexitouch Plus
Device: Flexitouch Plus FT with software modification

Registration Number: NCT04073823

Lead Sponsor: Tactile Medical

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 2

Inclusion Criteria

Female 18 years of age or older
Diagnosis of unilateral breast cancer-related lymphedema
Stage I or early stage II lymphedema without severe fibrosis at the time of enrollment
≥ 5% volume difference between affected and unaffected arm as verified via perometry
Willing and able to give informed consent
Willing and able to comply with the study protocol requirements and all study-related visit requirements

Exclusion Criteria

In-home use of PCD within previous 3 months
Therapist or self-administered manual lymph drainage (MLD) within previous 1 week
Mastectomy or lymph node removal on side without lymphedema
Bilateral lymphedema
Heart failure (acute pulmonary edema, decompensated acute heart failure)
Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
Active cancer (cancer that is currently under treatment, but not yet in remission)
Poorly controlled kidney disease (glomerular filtration rate < 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome
BMI >50
Any circumstance where increased lymphatic or venous return is undesirable
Currently pregnant or trying to become pregnant
Allergy to iodine

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexitouch Plus	Flexitouch Plus	-
Flexitouch Plus with SW	Flexitouch Plus FT with software modification	-

Primary Outcome Measures

Name	Time	Method
Lymphatic Activation	Baseline and following a single treatment, an average of one hour	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.
Changes in Swelling - Perometry	Baseline and following a single treatment, an average of one hour	Swelling in the affected and contralateral limb as assessed using local tissue water content
Changes in Swelling - MoistureMeterD	Baseline and following a single treatment, an average of one hour	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.
Percent Change in Skin Thickness From Baseline to After Treatment.	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).
Incidence of Adverse Events	24-Hour Follow-Up	Adverse events reported between treatment and the 24-hour follow-up
Absolute Change in Skin Thickness From Baseline to After Treatment	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).
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging	Baseline and following a single treatment, an average of one hour	Comparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging.
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging	Baseline and following a single treatment, an average of one hour	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
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)	Baseline and following a single treatment, an average of one hour	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
Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)	Baseline and following a single treatment, an average of one hour	Compare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner)