Status:
COMPLETED
Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.
Lead Sponsor:
Tactile Medical
Conditions:
Breast Cancer Lymphedema
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The objective of this study is to demonstrate the feasibility of using the Flexitouch Plus with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to patients impact co...
Detailed Description
This is a multi-center, on label, prospective, randomized, two-arm feasibility study that plans to enroll 30 female subjects in the United States. In an effort to reduce potential exposure to COVID-19...
Eligibility Criteria
Inclusion
- Female 18 years of age or older
- Diagnosis of unilateral breast cancer-related lymphedema
- Willing and able to give informed consent (remotely or in person)
- Willing and able to comply with the study protocol requirements and all study-related visit requirements, including the ability to participate remotely
- Willing and able to receive text messages from sponsor
Exclusion
- In-home use of PCD within previous 3 months
- Phase-one CDT within previous 1 month or planned phase-one CDT during study participation Phase-one CDT defined as professionally administered MLD and/or multi-layer short stretch compressive bandaging.
- Inability to be fit for PCD garments
- 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
- Currently receiving treatment for cancer with curative intent.
- Any circumstance where increased lymphatic or venous return is undesirable
- Currently pregnant or trying to become pregnant
- Known inability to receive cell phone connection where FT-CC therapy will be administered
Key Trial Info
Start Date :
August 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2021
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04432727
Start Date
August 13 2020
End Date
November 19 2021
Last Update
May 24 2023
Active Locations (3)
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1
University of Louisville
Louisville, Kentucky, United States, 40202
2
St. Peter's Hospital
Albany, New York, United States, 12208
3
Samaritan Hospital Hildegard Medicus Cancer Center
Troy, New York, United States, 12180