Trials / Terminated
TerminatedNCT04073823
A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients
A Feasibility Study Evaluating Flexitouch® Plus With a Therapy Cycle Software Modification in Patients With Unilateral Breast Cancer-Related Lymphedema (BCRL)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Tactile Medical · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-01-23
- Primary completion
- 2020-02-08
- Completion
- 2020-02-08
- First posted
- 2019-08-29
- Last updated
- 2023-01-18
- Results posted
- 2021-02-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04073823. Inclusion in this directory is not an endorsement.