Pilot Study of a Compact Pneumatic Compression Device for Patients With Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Usability of the Monterey Investigational System in a monitored clinic environment
研究概览
简要总结
This is a pilot study for usability and efficacy, and as such it is designed for 15 participants.
The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting.
The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting over one week of daily use. Usability will be determined using a 11 point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Patients who are ≥ 18 years, mentally able to understand and follow the instructions of the study personnel.
- •A diagnosis of lower limb Lymphedema.
- •Able to provide written and informed consent.
- •Patient can read and comprehend English.
排除标准
- •Subject undergoing cancer treatment.
- •Subject has active lower limb wounds.
- •Subject is pregnant or trying to become pregnant.
- •History of pulmonary edema or decompensated congestive heart failure.
- •Subject has any condition in which increased venous and lymphatic return is undesirable.
- •Subject has inbuilt electrical stimulator, e.g., cardiac pacemaker
研究组 & 干预措施
Monterey Pneumatic Compression Device
All participants will receive treatment with the Monterey investigational pneumatic compression device
干预措施: Monterey Pneumatic Compression Device (Device)
结局指标
主要结局
Usability of the Monterey Investigational System in a monitored clinic environment
时间窗: 1 week
Usability will be determined using a 11 point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.
次要结局
- Efficacy of Therapy provided by Monterey Investigational system(1 week)