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

Head and Neck Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03558672
• Other study ID #: 4060
• Status: Terminated
• Start date: September 14, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2020
• Source: Tactile Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Lymphedema
• Lymphedema

Intervention

Device:
• Flexitouch system with Head and Neck Garments
Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed

Locations

Country	Name	City	State
United States	Charles George VA Medical Center	Asheville	North Carolina
United States	The Ohio State University	Columbus	Ohio
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Iowa ENT Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Tactile Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Ease of Use/Satisfaction	Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured.	Assessed at 6 months