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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-14

Study Completion Date

2020-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Lymphedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Flexitouch system with Head and Neck Garments

Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No