Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in frequency of lymphatic pulsing as assessed by the number of lymphatic pulses per minute in each region imaged
研究概览
简要总结
The purpose of this study is to objectively assess lymphatic function before, during, and immediately after Neuroglide treatment in lower trunk and leg lymphatic vessels, torso, axillary regions, inguinal regions, upper extremities, and cervical/neck and to determine any VAS (Visual Analog Scale, a commonly used measure of pain perception) score change after Neuroglide treatment.
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
- •ambulatory and possess all four limbs
- •Female participants of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration
- •Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month following each imaging session in the study
- •Weight less than 400 lbs
排除标准
- •Women who are pregnant or breast-feeding
- •Persons who are allergic to iodine or indocyanine green
- •Heart failure, poorly controlled kidney disease (glomerular filtration rate <30 mls per minute), hypoproteinemia, pulmonary hypertension, or hypothyroidism
- •Any circumstance where increased lymphatic or venous return is undesirable
研究组 & 干预措施
Pneumatic Compression Therapy (PCT)
干预措施: Indocyanine green (ICG) dye (Drug)
Pneumatic Compression Therapy (PCT)
干预措施: NIRF-LI imaging (Device)
Pneumatic Compression Therapy (PCT)
干预措施: Neuroglide pad (Device)
结局指标
主要结局
Change in frequency of lymphatic pulsing as assessed by the number of lymphatic pulses per minute in each region imaged
时间窗: Baseline, during Neuroglide treatment ( 1 hour after NIRF-LI imaging ), 1 hour after PCT treatment
次要结局
- Change in pain as assessed by the Visual Analog Scale (VAS)(Baseline, 1 hour after PCT treatment, 4-8 weeks after imaging for data analysis completion)
研究者
Melissa B Aldrich
Associate Professor
The University of Texas Health Science Center, Houston