A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients With Breast Cancer Related Lymphedema (BCRL) After Lymphatic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- ICG Fluorescence Lymphatic Imaging
研究概览
简要总结
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
详细描述
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Males and females ≥ 18 years of age
- •Willing to sign the informed consent and deemed capable of following the study protocol
- •Subjects must have a diagnosis of upper extremity edema and have or will undergo lymphatic surgery with Dr. Nguyen
- •Subjects must have a difference in volume greater than 3% between the limbs.
排除标准
- •Individuals with a history or presence of a systemic disorder or condition that could place the patient at increased risk from sequential compression therapy
- •Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
- •Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
- •Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer
- •Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
- •Diagnosis of lipedema
- •Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study
- •Diagnosis of acute thrombophlebitis (in last 2 months)
- •Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
- •Diagnosis of pulmonary edema
- •Diagnosis of congestive heart failure (uncontrolled)
- •Diagnosis of chronic kidney disease
- •Diagnosis of epilepsy
- •Patients with poorly controlled asthma
- •Women who are pregnant, planning a pregnancy or nursing at study entry
- •Participation in any clinical trial of an investigational substance or device during the past 30 days
- •Bilateral limb edema
结局指标
主要结局
ICG Fluorescence Lymphatic Imaging
时间窗: Baseline and at Day 28
ICG fluorescence lymphatic imaging evaluates for changes in lymphatic drainage of the limb. ICG is a water soluble tricarbocyanine dye, has a short plasma half life of 3 to 5 minutes in humans, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. ICG contains sodium iodide and is recommended by manufacturer to be used with caution in patients who have a history of allergy to iodides, although type-I allergic reaction (anaphylaxis) cannot really occur because iodine is a chemical element that is an essential component of the human body.
次要结局
未报告次要终点