Clinical trial · Interventional
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)
NCT04073823CI-TRIAL-00063259terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to unforeseen slow enrollment and a shift in corporate resources due to the COVID-19 impact.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Related Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flexitouch Plus | Device | — | UNRESOLVED |
| Flexitouch Plus FT with software modification | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Flexitouch Plus
- interventionNames
- Device: Flexitouch Plus
- type
- EXPERIMENTAL
- label
- Flexitouch Plus with SW
- interventionNames
- Device: Flexitouch Plus FT with software modification
Primary outcomes (10)
- measure
- Lymphatic Activation
- timeFrame
- Baseline and following a single treatment, an average of one hour
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.