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A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients

NCT04073823 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-01-18

Study results available
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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 therapy cycle software.

Conditions

  • Breast Cancer Related Lymphedema

Interventions

DEVICE

Flexitouch Plus

Flexitouch Plus full arm and core treatment

DEVICE

Flexitouch Plus FT with software modification

Flexitouch Plus full arm and trunk/chest treatment

Sponsors & Collaborators

  • Tactile Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-23
Primary Completion
2020-02-08
Completion
2020-02-08
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 NCT04073823 on ClinicalTrials.gov