Cancer Clinical Trial
Official title:
a Prospective, Multicenter, Randomized, Open, Parallel Controlled Noninferiority Clinical Study to Evaluate the Efficacy and Safety of CathiportTM Implantable Drug Delivery Device
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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