A Prospective, Open-label, Cross-over, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA in Subjects Suffering From a Stage 5 Kidney Disease and Who Are Treated With Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 主要终点
- Safety Endpoint - Serious Adverse Events Rate
研究概览
简要总结
This is a multi-center, open label, cross-over clinical study. A total of 15 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days. To participate in the study, the subjects must have current CKD5 and have been treated with PD for at least 3 months. The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home.
The study includes three periods:
First period (Observational): 14-day Observational Period. Eligible subjects who sign informed consent will continue with their regular CAPD treatment while performing measurement and recording of dialysate in/out time.
Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule.
Third period (Follow up): 14-day follow up period, during which the study staff will call the subject once weekly to inquire about device-related SAEs and any changes to concomitant medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with CKD stage 5 under peritoneal dialysis
- •Age ≥18 years
- •Mental ability to understand the study procedures and provide informed consent
- •At least 3 months on peritoneal dialysis prior to enrollment
- •At least 3 daily exchanges
- •Stable PD prescription for the last 2 months
- •Subject who is self-treated
排除标准
- •Need of cycler (APD)
- •Known Mechanical problem during the last month (i.e. drainage or fill problems)
- •Pregnant or breastfeeding women, and women with childbearing potential who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period.
- •Subjects who are unwilling or unable to comply with study procedures
- •Known Peritonitis or other catheter related infection during the last 3 months prior to enrollment
- •Known Congestive Heart Failure stage III-IV
- •Any history of kidney malignancy
- •Any planned hospitalization for elective Procedure(s)throughout the duration of participation in the study
- •Non-elective hospitalization in the last 3 months prior to enrollment
- •Any other medical or mental condition, that at the investigator's discretion may prevent the subject from participating in the study
- •Participation in any other clinical study within 4 weeks prior to enrollment
结局指标
主要结局
Safety Endpoint - Serious Adverse Events Rate
时间窗: 42 days
The safety of the IDA, as determined by the accumulative incidence of device-related SAEs throughout the 14-day prospective study period
次要结局
- IDA Usability by Investigator(14 days)
- IDA Feasibility(14 days)
- IDA Usability by Subject(14 days)