Status:
TERMINATED
A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients
Lead Sponsor:
Tactile Medical
Conditions:
Breast Cancer Related Lymphedema
Eligibility:
FEMALE
18+ years
Phase:
NA
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 therap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04073823
Start Date
January 23 2020
End Date
February 8 2020
Last Update
January 18 2023
Active Locations (1)
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1
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030