A Single Arm, Prospective, Open Label, Cross-Over, Multi-Center Study to Evaluate the Safety, Feasability and Usability of the Intelligent Dialysis Assistant (IDA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- AE during on site exchange
研究概览
简要总结
This is a multi-center, open label, cross-over clinical study. A total of 18 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.
详细描述
This is a multi-center, open label, cross-over clinical study. A total of 20 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 two cohorts and two phases: in the first phase (phase I), 20 subjects will be recruited as Cohort 1 to undergo a single exchange in the medical center using the IDA. Following the completion of recruitment of all 20 subjects and the performance of the single on site exchange, the Sponsor will perform an interim analysis of the results for safety and initial feasibility, followed by submission of the results to the MoH and approval of the second phase (phase II). The expected timeframe between phase I and phase II is up to 4 weeks. An additional cohort, Cohort 2, will be added to Phase I, which will include additional ten (10) subjects. These subjects will undergo the same procedure at the dialysis clinic, with the addition of blood sampling for CBC and Chemistry two (2) hours ±30 minutes after the procedure. A total of 20 subjects from either cohort, meeting the inclusion and exclusion criteria of Cohort 1, will continue to complete the second phase of the study (Phase II).
Phase II of 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.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with CKD stage 5 treated by continuous ambulatory peritoneal dialysis (CAPD)
- •Male or female, Age >18 years
- •Mental ability to understand study procedures and provide an informed consent
- •More than 3 months on PD (Peritoneal Dialysis)
- •At least 3 daily exchanges
- •Self-treated subject
- •Stable PD prescription for the last month
排除标准
- •Need of cycler (APD, Automated Peritoneal Dialysis)
- •Known mechanical problem (drainage, fill) during the last month prior to enrollment
- •Pregnant or breastfeeding women
- •subject who is unwilling or unable to comply with study procedures
- •Known Peritonitis or other catheter associated infections during the last 3 months prior to enrollment
- •Known Congestive heart failure stage III- IV
- •Non-elective hospitalization during 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
AE during on site exchange
时间窗: 1 day
Incidence of device-related adverse events during the on-site exchange - phase I of the study.
Device-Related Serious Adverse Event Incidence
时间窗: 14 days
Incidence of device-related SAEs throughout the active investigational phase (14 days).
次要结局
- Procedure Time Length(14 days)
- Usability Questionnaire(14 days)
- Device-Related Serious Adverse Events Incidence During Follow Up Period(14 days)
- Renal Treatment Internal Questionnaire(42 days)