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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
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Develop a prospective, multicenter, randomized, open, parallel controlled noninferiority clinical trial to evaluate the efficacy and safety of CathiportTM implantable drug delivery device
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CathiportTM | Experimental | be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples. |
|
| Implant Port | Active Comparator | be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CathiportTM | Device | fully implanted |
| |
| Implant Port |
| Measure | Description | Time Frame |
|---|---|---|
| Normal usage rate of the equipment | The probability of normally drugs or liquid infusion | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of equipment | 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 |
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Inclusion Criteria:
Patient meet 1 and 8 firstly, and then meet any one item with 2-7 above can be accepted.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Device |
fully implanted |
|
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 | Catheter indwelling time | at 1,2,3,4,5,6 month |
| the evaluation of the convenience | all the operaters will give a convenience evaluation timely by answering the questionnare | intraoperative |
| the evaluation of the comfort | physical performance evaluation of the device | intraoperative |