A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Symptom/Problem Improvement From Baseline to 6 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Symptom/Problem Improvement From Baseline to 6 Months
时间窗: Percent Changes between Baseline and 6 months will be assessed
To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in symptoms/problems. Negative value shows a decrease in symptoms/problems. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
Function (Range of Motion) Improvement From Baseline to 6 Months
时间窗: Percent Changes between Baseline and 6 months will be assessed
To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in Function/Range of Motion. Negative value shows a decrease in Function/Range of Motion. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline.
次要结局
- Changes in Health-related Quality of Life From Baseline to 6 Months(Percent Changes between Baseline and 6 months will be assessed)
- Changes in Health-related Quality of Life-Overall From Baseline to 6 Months(Percent Changes between Baseline and 6 months will be assessed)
- Change in Swelling From Baseline to 6 Months(Percent Changes between Baseline and 6 months will be assessed)
- Changes in Pain From Baseline to 6 Months(Percent Changes between Baseline and 6 months will be assessed)
- Ease of Use/Satisfaction(Assessed at 6 months)