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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:September 6, 2018
End Date:June 2022
Contact:Jill Christensen
Email:jchristensen@tactilemedical.com
Phone:612-355-5123

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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.


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)
We found this trial at
2
sites
Asheville, North Carolina 28805
Principal Investigator: Julia Furdyna, MD
Phone: 828-298-7911
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Stephen Kang, MD
Phone: 614-685-8964
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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