CathiportTM Clinical Efficacy and Safety Evaluation

NCT03198312 | Unknown

• 1 other identifier: Branden-abc
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Normal usage rate of the equipment

  The probability of normally drugs or liquid infusion

  at 6 months

Secondary Outcomes (5)

• Success rate of equipment

  0 to 24 hours after implantation

• Success rate of surgery

  0 to 24 hours after operation

• the evaluation of the efficiency

  at 1,2,3,4,5,6 month

• the evaluation of the convenience

  intraoperative

• the evaluation of the comfort

  intraoperative

Study Arms (2)

CathiportTM

EXPERIMENTAL

be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples.

Device: CathiportTM

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.

Device: Implant Port

Interventions

CathiportTM DEVICE

fully implanted

CathiportTM

Implant Port DEVICE

fully implanted

Implant Port

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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）.

Sponsors & Collaborators

• Shandong Branden Med.Device Co.,Ltd: lead
• Shanghai Zhongshan Hospital: collaborator

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 26, 2017
• Study Start: October 20, 2016
• Primary Completion: October 20, 2017
• Study Completion: January 20, 2018
• Last Updated: June 26, 2017

Record last verified: 2017-06