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

NCT04073823 | Terminated Results FDA Device

• 1 other identifier: 4070
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (10)

• 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

• 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.

Study Arms (2)

Flexitouch Plus

ACTIVE COMPARATOR

Device: Flexitouch Plus

Flexitouch Plus with SW

EXPERIMENTAL

Device: Flexitouch Plus FT with software modification

Interventions

Flexitouch Plus DEVICE

Flexitouch Plus full arm and core treatment

Flexitouch Plus

Flexitouch Plus FT with software modification DEVICE

Flexitouch Plus full arm and trunk/chest treatment

Also known as: FT-SW

Flexitouch Plus with SW

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tactile Medical: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michelle Wetherby
• Organization: Tactile Medical

mwetherby@tactilemedical.com

612.230.4576

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 29, 2019
• Study Start: January 23, 2020
• Primary Completion: February 8, 2020
• Study Completion: February 8, 2020
• Last Updated: January 18, 2023
• Results First Posted: February 17, 2021

Record last verified: 2023-01

Locations

US (1)