Evaluation of the Safety & Performance of the Aquapass -Medical Device, for Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Device related Adverse Events
研究概览
简要总结
To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin.
详细描述
This study requires several investigational tests, exams, and data collection procedures to be performed by the participants. These procedures are listed in abbreviated format in the Schedule of Assessments/Activities table. The final eligibility of the trial will be confirmed after a 2-hour acclimatization session. The trial-specific procedures must not be performed until the participant has signed a written informed consent form, which has been approved by the site's Institutional Review Board.
The investigator or designee, who is trained in the clinical investigation plan, will explain the nature and scope of the trial to the participant. They will also discuss the potential risks and benefits of participation and answer any questions the participant may have. If the participant agrees to participate, they must sign the informed consent form. The investigator/designee must also sign the form before the participant can be enrolled in the trial. Any additional persons required by the site's Institutional Review Board to sign the informed consent form must also comply.
Each participant's study duration will be approximately 8 weeks. The study duration will be identical for all participants, as follows:
Screening Period: This period will last up to 7 days, during which time the participant's eligibility for the trial will be determined.
Observation Period: This period will last 3 weeks, during which the participant will come to the medical study center for weekly assessments.
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
- •Undergoing regular hemodialysis for ≥3 months
- •Subject is capable of meeting study requirements including follow-up visit
- •Subject completed 2-hour acclimatization session
排除标准
- •Subject is enrolled to another clinical investigation that might interfere with this study
- •Subject does not have any known skin problems (open or uncovered wounds, ulcers)
- •Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
- •Scheduled living donor renal transplant during study participation
- •Has resting pre-dialysis systolic blood pressure <100mmHg
- •Limb/s amputation
- •Hyperkalemia > 6meq/d"l
结局指标
主要结局
Device related Adverse Events
时间窗: Up to 60 Days
Safety evaluation of device-related adverse effects
Differences in weight gain over the long interdialytic period
时间窗: Up to 50 days
weight at the end of the last Hemodialysis session before AquaPass therapy subtracted from the weight in the morning of the first Hemodialysis session of the week after AquaPass therapy.
次要结局
- Effect on Quality of Life(up to 50 days)
- Changes in NT-proBNP(Up to 50 days)
- Changes in Blood Urea Nitrogen(Up to 50 days)
- Affect on Ultrafiltration Rates after the long inter dialytic gap(up to 28 days)