CathiportTM Clinical Efficacy and Safety Evaluation
a Prospective, Multicenter, Randomized, Open, Parallel Controlled Noninferiority Clinical Study to Evaluate the Efficacy and Safety of CathiportTM Implantable Drug Delivery Device
研究概览
详细说明
I-Port is also called the implantable infusion Port typed central venous catheter and suite, it is a kind of the closed venous infusion system that can fully implanted, can be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples, It can be used to reduce painfulness and the difficulty of repeated venipuncture, to prevent external stimulants weeks vein injury, and the daily life of patients is not limited, they don't need to change medicine, can bathe, so can improve the quality of life.
The purpose of the study is to evaluate the safety and efficacy of the CathiportTM. The CathiportTM will be compared to an active control group represented by the FDA approved commercially available Bard Implant Port.
The study consists of a randomized clinical trial (RCT) in China which will enroll approximately 220 subjects (1:1 randomization CathiportTM : Implant Port) with patients required repeated and chronic drug input and fluid.
All subjects in the RCT will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the Implant Port of US RCT.
All subjects will have clinical follow-up at 1, 2, 3, 4, 5, 6 months and be provided nursing service to t maintain he Port , and verify whether the pipe is blocked and to prevent the Port into the liquid pipe clogging, and to observe the hematoma and infection situation of the operation or puncture points, observe whether if there is blocking pipe, and fluid extravasation surrounding skin tissue of judging when using, whether there are conditions such as shift or discount.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Older than 18 years old;
- Need for long-term intravenous fluids;
- Lack of peripheral venous access ;
- Need stimulants infusion, such as chemotherapy drugs;
- Need infusion of high permeability or sticky liquid, such as parenteral nutrient solution, fat emulsion;
- Need repeated blood or blood products transfusion and repeated blood collection;
- Fit and need implanted Port;
- Willing to participate in clinical research and signed informed consent;
Patient meet 1 and 8 firstly, and then meet any one item with 2-7 above can be accepted.
Exclusion Criteria:
- Cancer patients whose vascular related to the surgery is compressed ;
- Women patients with pregnancy and lactation;
- Participate other studies before achieving the primary end point already;
- Confirmed or suspected catheter-related infections, disseminated intravascular coagulation, bacteremia, sepsis;
- Body size is not suitable for implanting the infusion port ;
- Confirmed or suspected allergic to silicone material;
- Having a history of radiation therapy at the pre-implant site;
- Having occurred acute myocardial infarction within 1 week or stroke in the past 6 months;
- Having a history of venous thrombosis, trauma, or vascular surgery;
- Superior vena cava syndrome;
- Having poor compliance behavior;
- Having installed the cardiac pacemaker device, bypass, accepted heart transplant or diagnosed with kidney failure(GFR≤30ml/Min).
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:CathiportTM
be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples.
|
fully implanted
|
有源比较器:Implant Port
be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples.
|
fully implanted
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Normal usage rate of the equipment
大体时间:at 6 months
|
The probability of normally drugs or liquid infusion
|
at 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Success rate of equipment
大体时间:0 to 24 hours after implantation
|
Refers to the equipment can be get to the therapeutic part as expected successfully , the catheter can infused smoothly and the blood samples can be get back normally
|
0 to 24 hours after implantation
|
Success rate of surgery
大体时间:0 to 24 hours after operation
|
The fluid can be infused and withdraw normally, and no pneumothorax, air embolism, mediastinal hematoma surgical complications appeared
|
0 to 24 hours after operation
|
the evaluation of the efficiency
大体时间:at 1,2,3,4,5,6 month
|
Catheter indwelling time
|
at 1,2,3,4,5,6 month
|
the evaluation of the convenience
大体时间:intraoperative
|
all the operaters will give a convenience evaluation timely by answering the questionnare
|
intraoperative
|
the evaluation of the comfort
大体时间:intraoperative
|
physical performance evaluation of the device
|
intraoperative
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Branden-abc
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研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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