An interventional study of Flexitouch Plus and Flexitouch Plus FT with software modification in Breast Cancer Related Lymphedema, sponsored by Tactile Medical. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Tactile Medical · Not applicable, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 2 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Tactile Medical is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Flexitouch Plus
Device: Flexitouch Plus FT with software modification
Flexitouch Plus full arm and core treatment
Flexitouch Plus full arm and trunk/chest treatment
Also known as: FT-SW
Lymphatic Activation
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.
Time frame: Baseline and following a single treatment, an average of one hour
Changes in Swelling - MoistureMeterD
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.
Time frame: Baseline and following a single treatment, an average of one hour
Changes in Swelling - Perometry
Swelling in the affected and contralateral limb as assessed using local tissue water content
Time frame: Baseline and following a single treatment, an average of one hour
Percent Change in Skin Thickness From Baseline to After Treatment.
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
Incidence of Adverse Events
Adverse events reported between treatment and the 24-hour follow-up
Time frame: 24-Hour Follow-Up
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
Comparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging.
Time frame: Baseline and following a single treatment, an average of one hour
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
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
Time frame: 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)
Compare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner)
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)
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
Time frame: Baseline and following a single treatment, an average of one hour
Absolute Change in Skin Thickness From Baseline to After Treatment
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.
| Milestone | Flexitouch Plus | Flexitouch Plus With SW |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
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.
| Percent Rate Change | Flexitouch Plus | Flexitouch Plus With SW |
|---|---|---|
| Affected Limb | 0.0 | -50 |
| Contralateral Limb | -3.0 | 241.2 |
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.
| Percent Change | Flexitouch Plus | Flexitouch Plus With SW |
|---|---|---|
| Changes in Swelling - MoistureMeterD | -4.0 (-7.4 to 0.0) | -6.4 (-11.4 to 3.8) |
Swelling in the affected and contralateral limb as assessed using local tissue water content
| Percent Change | Flexitouch Plus | Flexitouch Plus With SW |
|---|---|---|
| Affected Limb | 1.6 | -1.6 |
| Contralateral Limb | 0.5 | 0.7 |
Skin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
| Percent Change | Flexitouch Plus | Flexitouch Plus With SW |
|---|---|---|
| Affected Limb Percent Change | 116.1 (-46.5 to 310.3) | 5.6 (-17.0 to 76.1) |
| Contralateral Limb Percent Change | 15.2 (-56.4 to 106.9) | 184.2 (-4.3 to 670.8) |
Adverse events reported between treatment and the 24-hour follow-up
| Participants | Flexitouch Plus | Flexitouch Plus With SW |
|---|---|---|
| Incidence of Adverse Events | 0 | 0 |
Comparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging.
| Participants | Flexitouch Plus | Flexitouch Plus With SW |
|---|---|---|
| Affected Limb | 0 | 0 |
| Contralateral Limb | 1 | 1 |
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
| Percent Change | Flexitouch Plus | Flexitouch Plus With SW |
|---|---|---|
| Affected Limb (Lateral Lower) | 65.4 | 20.6 |
| Contralateral Limb (Lateral Lower) | 0.0 | 0.0 |
| Affected Limb (Medial Lower) | 19.0 | -19.8 |
| Contralateral Limb (Medial Lower) | 0.0 | 0.0 |
| Affected Limb (Medial Upper) | 47.8 | 0.0 |
| Contralateral Limb (Medial Upper) | 0.0 | 0.0 |
Compare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner)
| Percentage of Participants | Flexitouch Plus | Flexitouch Plus With SW |
|---|---|---|
| Affected Limb | 0 | 100 |
| Contralateral Limb | 0 | 0 |
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
| Percent of Participants | Flexitouch Plus | Flexitouch Plus With SW |
|---|---|---|
| Skin Thickness (Site A) | 100 | 100 |
| Skin Thickness (Site B) | 0 | 100 |
| Skin Thickness (Site C) | 0 | 100 |
| Subcutaneous Thickness (Site A) | 0 | 100 |
| Subcutaneous Thickness (Site B) | 0 | 0 |
| Subcutaneous Thickness (Site C) | 100 | 0 |
Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
| mm | Flexitouch Plus | Flexitouch Plus With SW |
|---|---|---|
| Affected Limb Absolute Change | -1.70 (-8.25 to 0.11) | -0.03 (-1.18 to 0.6) |
| Contralateral Limb Absolute Change | -0.52 (-1.86 to 0.31) | -1.54 (-6.44 to 0.04) |
Collected over Adverse event assessment will occur during the acute study period and ~24 hours after the acute study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Flexitouch Plus | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Flexitouch Plus With SW | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Continuous(years) | Flexitouch Plus | Flexitouch Plus With SW | Total |
|---|---|---|---|
| Mean | 53 (53 to 53) | 81 (81 to 81) | 67 (53 to 81) |
| Sex: Female, Male(Participants) | Flexitouch Plus | Flexitouch Plus With SW | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Flexitouch Plus | Flexitouch Plus With SW | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Flexitouch Plus | Flexitouch Plus With SW | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tactile Medical