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CathiportTM Clinical Efficacy and Safety Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03198312
Recruitment Status : Unknown
Verified June 2017 by Shandong Branden Med.Device Co.,Ltd.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
Shanghai Zhongshan Hospital
Information provided by (Responsible Party):
Shandong Branden Med.Device Co.,Ltd

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

Condition or disease Intervention/treatment Phase
Cancer Device: CathiportTM Device: Implant Port Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: a Prospective, Multicenter, Randomized, Open, Parallel Controlled Noninferiority Clinical Study to Evaluate the Efficacy and Safety of CathiportTM Implantable Drug Delivery Device
Actual Study Start Date : October 20, 2016
Estimated Primary Completion Date : October 20, 2017
Estimated Study Completion Date : January 20, 2018

Arm Intervention/treatment
Experimental: CathiportTM
be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples.
Device: CathiportTM
fully implanted

Active Comparator: Implant Port
be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples.
Device: Implant Port
fully implanted




Primary Outcome Measures :
  1. Normal usage rate of the equipment [ Time Frame: at 6 months ]
    The probability of normally drugs or liquid infusion


Secondary Outcome Measures :
  1. Success rate of equipment [ Time Frame: 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

  2. Success rate of surgery [ Time Frame: 0 to 24 hours after operation ]
    The fluid can be infused and withdraw normally, and no pneumothorax, air embolism, mediastinal hematoma surgical complications appeared

  3. the evaluation of the efficiency [ Time Frame: at 1,2,3,4,5,6 month ]
    Catheter indwelling time

  4. the evaluation of the convenience [ Time Frame: intraoperative ]
    all the operaters will give a convenience evaluation timely by answering the questionnare

  5. the evaluation of the comfort [ Time Frame: intraoperative ]
    physical performance evaluation of the device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Older than 18 years old;
  2. Need for long-term intravenous fluids;
  3. Lack of peripheral venous access ;
  4. Need stimulants infusion, such as chemotherapy drugs;
  5. Need infusion of high permeability or sticky liquid, such as parenteral nutrient solution, fat emulsion;
  6. Need repeated blood or blood products transfusion and repeated blood collection;
  7. Fit and need implanted Port;
  8. 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:

  1. Cancer patients whose vascular related to the surgery is compressed ;
  2. Women patients with pregnancy and lactation;
  3. Participate other studies before achieving the primary end point already;
  4. Confirmed or suspected catheter-related infections, disseminated intravascular coagulation, bacteremia, sepsis;
  5. Body size is not suitable for implanting the infusion port ;
  6. Confirmed or suspected allergic to silicone material;
  7. Having a history of radiation therapy at the pre-implant site;
  8. Having occurred acute myocardial infarction within 1 week or stroke in the past 6 months;
  9. Having a history of venous thrombosis, trauma, or vascular surgery;
  10. Superior vena cava syndrome;
  11. Having poor compliance behavior;
  12. Having installed the cardiac pacemaker device, bypass, accepted heart transplant or diagnosed with kidney failure(GFR≤30ml/Min).

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Responsible Party: Shandong Branden Med.Device Co.,Ltd
ClinicalTrials.gov Identifier: NCT03198312    
Other Study ID Numbers: Branden-abc
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No