NCT03198312

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Shandong Branden Med.Device Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Develop a prospective, multicenter, randomized, open, parallel controlled noninferiority clinical trial to evaluate the efficacy and safety of CathiportTM implantable drug delivery device

Detailed description

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DEVICE	CathiportTM	fully implanted
DEVICE	Implant Port	fully implanted

Timeline

• Start date: 2016-10-20
• Primary completion: 2017-10-20
• Completion: 2018-01-20
• First posted: 2017-06-26
• Last updated: 2017-06-26