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

NCT04432727 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-05-24

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

Conditions

  • Breast Cancer Lymphedema

Interventions

DEVICE

Flexitouch Plus with Cellular Connectivity (FT-CC)

Daily use of FT-CC

Sponsors & Collaborators

  • Tactile Medical

    lead INDUSTRY

Principal Investigators

  • Sarah Pesek, MD · St. Peter's Health Partners

  • Nicolas Ajkay, MD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2021-11-19
Completion
2021-11-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04432727 on ClinicalTrials.gov