- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04073823
A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients
January 5, 2023 updated by: Tactile Medical
A Feasibility Study Evaluating Flexitouch® Plus With a Therapy Cycle Software Modification in Patients With Unilateral Breast Cancer-Related Lymphedema (BCRL)
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female 18 years of age or older
- Diagnosis of unilateral breast cancer-related lymphedema
- Stage I or early stage II lymphedema without severe fibrosis at the time of enrollment
- ≥ 5% volume difference between affected and unaffected arm as verified via perometry
- Willing and able to give informed consent
- Willing and able to comply with the study protocol requirements and all study-related visit requirements
Exclusion Criteria:
- In-home use of PCD within previous 3 months
- Therapist or self-administered manual lymph drainage (MLD) within previous 1 week
- Mastectomy or lymph node removal on side without lymphedema
- Bilateral lymphedema
- 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
- Active cancer (cancer that is currently under treatment, but not yet in remission)
- Poorly controlled kidney disease (glomerular filtration rate < 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome
- BMI >50
- Any circumstance where increased lymphatic or venous return is undesirable
- Currently pregnant or trying to become pregnant
- Allergy to iodine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Flexitouch Plus
|
Flexitouch Plus full arm and core treatment
|
Experimental: Flexitouch Plus with SW
|
Flexitouch Plus full arm and trunk/chest treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lymphatic Activation
Time Frame: Baseline and following a single treatment, an average of one hour
|
Comparison of the change in the rate of lymphatic propulsion events from the pre-treatment values to the post-treatment values for both the affected and contralateral limbs using the investigational technique of near infrared-fluorescent (NIRF) imaging.
|
Baseline and following a single treatment, an average of one hour
|
Changes in Swelling - MoistureMeterD
Time Frame: Baseline and following a single treatment, an average of one hour
|
Comparison of the percent change in local tissue water from the pre-treatment values to the post-treatment values on the affected limb using MoistureMeterD.
|
Baseline and following a single treatment, an average of one hour
|
Changes in Swelling - Perometry
Time Frame: Baseline and following a single treatment, an average of one hour
|
Swelling in the affected and contralateral limb as assessed using local tissue water content
|
Baseline and following a single treatment, an average of one hour
|
Incidence of Adverse Events
Time Frame: 24-Hour Follow-Up
|
Adverse events reported between treatment and the 24-hour follow-up
|
24-Hour Follow-Up
|
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
Time Frame: Baseline and following a single treatment, an average of one hour
|
Comparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging.
|
Baseline and following a single treatment, an average of one hour
|
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
Time Frame: Baseline and following a single treatment, an average of one hour
|
Comparison of the change in dermal backflow from the pre-treatment values to the post-treatment values as the sum of the volume of area for all locations for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging
|
Baseline and following a single treatment, an average of one hour
|
Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)
Time Frame: Baseline and following a single treatment, an average of one hour
|
Compare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner)
|
Baseline and following a single treatment, an average of one hour
|
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Time Frame: Baseline and following a single treatment, an average of one hour
|
Comparison of the percent of participants by arm demonstrating a decrease in thickness for each site, separating skin and subcutaneous changes, on the affected limb via Ultrasound
|
Baseline and following a single treatment, an average of one hour
|
Percent Change in Skin Thickness From Baseline to After Treatment.
Time Frame: Baseline and following a single treatment, an average of one hour
|
Skin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
|
Baseline and following a single treatment, an average of one hour
|
Absolute Change in Skin Thickness From Baseline to After Treatment
Time Frame: Baseline and following a single treatment, an average of one hour.
|
Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
|
Baseline and following a single treatment, an average of one hour.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 23, 2020
Primary Completion (Actual)
February 8, 2020
Study Completion (Actual)
February 8, 2020
Study Registration Dates
First Submitted
July 25, 2019
First Submitted That Met QC Criteria
August 27, 2019
First Posted (Actual)
August 29, 2019
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
January 5, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4070
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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