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

Tactile Medical

Status: Terminated

Conditions: Head and Neck Lymphedema

Treatments: Device: Flexitouch system with Head and Neck Garments

Study type: Observational

Funder types: Industry

Identifiers

NCT03558672

4060

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design