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Due to unforeseen slow enrollment and a shift in corporate resources due to the COVID-19 impact.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexitouch Plus | Active Comparator |
| |
| Flexitouch Plus with SW | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexitouch Plus | Device | Flexitouch Plus full arm and core treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 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). | 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 | 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. | Baseline and following a single treatment, an average of one hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flexitouch Plus | Flexitouch Plus: Flexitouch Plus full arm and core treatment |
| FG001 | Flexitouch Plus With SW | Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flexitouch Plus | Flexitouch Plus: Flexitouch Plus full arm and core treatment |
| BG001 | Flexitouch Plus With SW | Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Percent Rate Change | Baseline and following a single treatment, an average of one hour |
|
Adverse event assessment will occur during the acute study period and ~24 hours after the acute study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flexitouch Plus | Flexitouch Plus: Flexitouch Plus full arm and core treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Wetherby | Tactile Medical | 612.230.4576 | mwetherby@tactilemedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2019 | Nov 19, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
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| Flexitouch Plus FT with software modification |
| Device |
Flexitouch Plus full arm and trunk/chest treatment |
|
|
| 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 | 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) | 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 | 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). | Baseline and following a single treatment, an average of one hour. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Mean | Full Range | Percent Change | Baseline and following a single treatment, an average of one hour |
|
|
|
| Primary | Changes in Swelling - Perometry | Swelling in the affected and contralateral limb as assessed using local tissue water content | Posted | Number | Percent Change | Baseline and following a single treatment, an average of one hour |
|
|
|
| Primary | Percent Change in Skin Thickness From Baseline to After Treatment. | Skin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound). | Posted | Mean | Full Range | Percent Change | Baseline and following a single treatment, an average of one hour |
|
|
|
| Primary | Incidence of Adverse Events | Adverse events reported between treatment and the 24-hour follow-up | Posted | Count of Participants | Participants | 24-Hour Follow-Up |
|
|
|
| Primary | 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. | Posted | Number | Participants | Baseline and following a single treatment, an average of one hour |
|
|
|
| Primary | 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 | Posted | Number | Percent Change | Baseline and following a single treatment, an average of one hour |
|
|
|
| Primary | 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) | Posted | Number | Percentage of Participants | Baseline and following a single treatment, an average of one hour |
|
|
|
| Primary | 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 | Posted | Number | Percent of Participants | Baseline and following a single treatment, an average of one hour |
|
|
|
| Primary | Absolute Change in Skin Thickness From Baseline to After Treatment | Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound). | Posted | Mean | Full Range | mm | Baseline and following a single treatment, an average of one hour. |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Flexitouch Plus With SW | Flexitouch Plus FT with software modification: Flexitouch Plus full arm and trunk/chest treatment | 0 | 1 | 0 | 1 | 0 | 1 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Affected Limb (Medial Lower) |
|
| Contralateral Limb (Medial Lower) |
|
| Affected Limb (Medial Upper) |
|
| Contralateral Limb (Medial Upper) |
|
| Skin Thickness (Site C) |
|
| Subcutaneous Thickness (Site A) |
|
| Subcutaneous Thickness (Site B) |
|
| Subcutaneous Thickness (Site C) |
|