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Active Clinical Trials

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

Active NCT:
03558672
Allegheny General Hospital
Allegheny General Hospital

Federal North Building
Federal North Building

Forbes Hospital
Forbes Hospital

Wexford Health + Wellness Pavilion
Wexford Health + Wellness Pavilion

Sponsor: 
Tactile Medical
Contact: 

For more information, please contact Josh Woolford at 412-359-3826 or Josh.Woolford@ahn.org.

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

Purpose: 

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.

Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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

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, acute or 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

History of pulmonary edema or congestive heart failure

Subject is pregnant or trying to become pregnant