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

Tactile Medical

Status: Terminated

Conditions: Breast Cancer Related Lymphedema

Treatments: Device: Flexitouch Plus FT with software modification; Device: Flexitouch Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT04073823

4070

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups

Flexitouch Plus

Active Comparator group

Treatment:

Device: Flexitouch Plus

Flexitouch Plus with SW

Experimental group

Treatment:

Device: Flexitouch Plus FT with software modification