Clinical trial NCT03558672: A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema
Official title: A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head and Neck Lymphedema
Keywords: Flexitouch
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Symptom/Problem Improvement From Baseline to 6 Months
timeFrame: Percent Changes between Baseline and 6 months will be assessed
measure: Function (Range of Motion) Improvement From Baseline to 6 Months
timeFrame: Percent Changes between Baseline and 6 months will be assessed
Secondary outcomes:
measure: Changes in Health-related Quality of Life From Baseline to 6 Months
timeFrame: Percent Changes between Baseline and 6 months will be assessed
measure: Changes in Health-related Quality of Life-Overall From Baseline to 6 Months
timeFrame: Percent Changes between Baseline and 6 months will be assessed
measure: Changes in Pain From Baseline to 6 Months
timeFrame: Percent Changes between Baseline and 6 months will be assessed
measure: Change in Swelling From Baseline to 6 Months
timeFrame: Percent Changes between Baseline and 6 months will be assessed
measure: Ease of Use/Satisfaction
timeFrame: Assessed at 6 months
Other outcomes:
Locations:
city: West Des Moines
country: United States
facility: Iowa ENT Center
state: Iowa
city: Asheville
country: United States
facility: Charles George VA Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
References: