Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.

Completed · Not applicable

Conditions studied: Breast Cancer Lymphedema

In brief

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 compliance, and to identify the impact device compliance has on arm girth, quality of life (QOL), and symptom assessment.

Key facts

Study ID

NCT04432727

Run by

Tactile Medical

People needed

29

Starts

2020-08-13

Expected to finish

2021-11-19

Last updated by the study team

2023-05-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Louisville — Louisville, Kentucky, United States
• St. Peter's Hospital — Albany, New York, United States
• Samaritan Hospital Hildegard Medicus Cancer Center — Troy, New York, United States

Full record on ClinicalTrials.gov

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