A Prospective Multicenter Investigation to Evaluate the Safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- Number of Adverse events
研究概览
简要总结
The study was designed to establish the safety of the Bayston Antimicrobial PD catheter that is impregnated with a "cocktail" of three well known anti-microbials
详细描述
The objective of this clinical investigation is to establish the safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD patients initiating CAPD.
The Bayston catheter is not expected to cause any safety related complications or reactions other than those described for not-impregnated peritoneal dialysis catheters. Thus the objective of this clinical investigation is to evaluate whether the Bayston catheter causes any unanticipated serious adverse device effects (USADE).
The primary hypothesis for this study is that the Bayston Antimicrobial Peritoneal Dialysis Catheter is a safe catheter for peritoneal dialysis.
No claims regarding efficacy will be verified during this clinical investigation.
This is a prospective, non-randomized, single-arm, multi-center study involving patients suffering from end stage renal disease who are eligible for treatment with peritoneal dialysis. Forty-three (43) patients will be enrolled who will be followed up to 6 months after implantation of the Bayston Antimicrobial Peritoneal Dialysis Catheter.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage renal disease documented by clinical symptoms and/or laboratory findings
- •Patients scheduled for their first PD catheter implantation
- •Eligible for peritoneal dialysis (CAPD)
- •Willing and able to attend all study follow-up visits
- •Willing and able to understand and sign the informed consent form
排除标准
- •A history of allergy to rifampin, trimethoprim or triclosan
- •Use contact lenses or have lens implants
- •Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
- •Recent abdominal surgery, abdominal adhesions, infected abdominal wall, diaphragmatic tears or ileus
- •Respiratory insufficiency
- •Infection:
- •Active infections from successful completion of antibiotic treatment for routine bacterial infection less than 4 weeks of entry into the clinical investigation (screening)
- •Febrile viral infection within 4 weeks of entry into the clinical investigation (screening)
- •Less than 12 weeks from conclusion of therapy for systemic fungal infections to screening
- •Abnormal hematology parameters defined as severe anemia with hemoglobin <8.5g/dL, white blood cell count of <3,500/μl and a granulocyte count <2,000/μl
- •Have collagen-vascular, connective tissue, or bleeding disorders
- •Used an investigational medicinal product, biologic or device within the last 30 days prior to enrollment
结局指标
主要结局
Number of Adverse events
时间窗: 6 months
Safety: Freedom from unanticipated serious device related adverse events up to 6 months after implantation of the Bayston catheter.
次要结局
未报告次要终点