Evaluation of the Safety & Performance of the AquaPass Medical Device, for Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Healthy Volunteers and Chronic Edematous Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Safety Events
研究概览
简要总结
The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.
详细描述
This is a prospective, single-center, open label single arm study, conducted in two phases: up to 6 healthy subjects (Phase 1) and up to 16 chronic heart failure (CHF) patients (Phase 2).
After being informed about the study, requirements and potential risks, consenting patients will be enrolled and undergo 3 procedures (each procedure up to 3 (±1) hours operation), with 4-10 days between each procedure.
All patients will be followed up for 7 (±2) days from final procedure.
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
- 是
入选标准
- •Phase 1: Healthy subjects:
- •Subject has been informed on the nature of the study and has provided informed consent
- •Subject is capable of meeting study requirements
- •Phase 2: CHF Patients:
- •Age ≥ 18 and diagnosed with CHF
- •Subject has 2 or more score for pitting edema
- •Subject is taking diuretic medications at home
- •Subject has been informed on the nature of the study and has provided informed consent
- •Subject is capable of meeting study requirements
排除标准
- •Phase 1: Healthy subjects:
- •Subject is enrolled to another clinical investigation that might interfere with this study
- •Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
- •Subject has no known sensitivity to Neoprene
- •Phase 2: CHF Patients:
- •Subject is enrolled to another clinical investigation that might interfere with this study
- •Subject is admitted to the hospital for acute decompensated or acute heart failure
- •Subject has any known lower body skin problems (open wounds, ulcers)
- •eGFR<15 ml/min/m2
- •Subject with severe peripheral arterial disease
- •Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
- •Subject has known sensitivity to Neoprene
结局指标
主要结局
Safety Events
时间窗: 30 days
Device related SAE
System Activation
时间窗: During procedure
Ability to activate the AquaPass System and control skin temperature to levels between 33°C and 38°C
Treatment Toleration
时间窗: During procedure
Subjects can tolerate at least 2 hours of treatment
次要结局
未报告次要终点