A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema

The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Lymphedema
• Intervention / Treatment: Device: Flexitouch system with Head and Neck Garments

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa ENT Center
  • North Carolina
    • Asheville, North Carolina, United States, 28805
      • Charles George VA Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment

Description

Inclusion Criteria:

• Age ≥ 18 years
• A diagnosis of head and/or neck lymphedema
• Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation
• Head and chest measurements within the following:
• Crown of head circumference: ≤ 72 cm
• Chest circumference: ≤ 158 cm
• Prescribed the Flexitouch system or Flexitouch Plus

Exclusion Criteria:

• Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression)
• Carotid sinus hypersensitivity syndrome
• Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
• Symptomatic bradycardia in the absence of a pacemaker
• Internal jugular venous thrombosis (within 3 months)
• Increased intracranial pressure or other contraindications to internal or external jugular venous compression
• Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), or surgical flap less than 6-8 weeks post-operative
• Facial or head and neck dermal metastasis
• Acute facial infection (e.g., facial or parotid gland abscess)
• Any condition in which increased venous and lymphatic return is undesirable
• Heart failure (acute pulmonary edema, decompensated acute heart failure)
• Subject is pregnant or trying to become pregnant
• Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom/Problem Improvement From Baseline to 6 Months	To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in symptoms/problems. Negative value shows a decrease in symptoms/problems. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.	Percent Changes between Baseline and 6 months will be assessed
Function (Range of Motion) Improvement From Baseline to 6 Months	To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in Function/Range of Motion. Negative value shows a decrease in Function/Range of Motion. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline.	Percent Changes between Baseline and 6 months will be assessed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Health-related Quality of Life From Baseline to 6 Months	Subject Quality of Life will be assessed using EORTC C30 questionnaire. Positive value shows an decrease in quality of life. Negative value shows a increase in quality of life. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.	Percent Changes between Baseline and 6 months will be assessed
Changes in Health-related Quality of Life-Overall From Baseline to 6 Months	Subject overall health and quality of life in the past week-EORTC C30. Positive value shows an increase in quality of life/overall health. Negative value shows a decrease in quality of life/overall health. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.	Percent Changes between Baseline and 6 months will be assessed
Changes in Pain From Baseline to 6 Months	Pain will be assessed using the VAS Pain Scale. Positive value shows an increase in pain. Negative value shows a decrease in pain. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.	Percent Changes between Baseline and 6 months will be assessed
Change in Swelling From Baseline to 6 Months	Swelling will be assessed using the ALOHA measurement protocol. Positive value shows an increase in swelling. Negative value shows a decrease in swelling. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline.	Percent Changes between Baseline and 6 months will be assessed
Ease of Use/Satisfaction	Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured.	Assessed at 6 months

Collaborators and Investigators

• Sponsor: Tactile Medical

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2018
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: May 10, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (ACTUAL): June 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Flexitouch
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 4060

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