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
Verified date | June 2017 |
Source | Shandong Branden Med.Device Co.,Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Develop a prospective, multicenter, randomized, open, parallel controlled noninferiority clinical trial to evaluate the efficacy and safety of CathiportTM implantable drug delivery device
Status | Active, not recruiting |
Enrollment | 220 |
Est. completion date | January 20, 2018 |
Est. primary completion date | October 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shandong Branden Med.Device Co.,Ltd | Shanghai Zhongshan Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Normal usage rate of the equipment | The probability of normally drugs or liquid infusion | at 6 months | |
Secondary | 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 | |
Secondary | Success rate of surgery | The fluid can be infused and withdraw normally, and no pneumothorax, air embolism, mediastinal hematoma surgical complications appeared | 0 to 24 hours after operation | |
Secondary | the evaluation of the efficiency | Catheter indwelling time | at 1,2,3,4,5,6 month | |
Secondary | the evaluation of the convenience | all the operaters will give a convenience evaluation timely by answering the questionnare | intraoperative | |
Secondary | the evaluation of the comfort | physical performance evaluation of the device | intraoperative |
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