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
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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）.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: CathiportTM
be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples.
|
fully implanted
|
|
Aktiv komparator: Implant Port
be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples.
|
fully implanted
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Normal usage rate of the equipment
Tidsramme: at 6 months
|
The probability of normally drugs or liquid infusion
|
at 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Success rate of equipment
Tidsramme: 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
|
0 to 24 hours after implantation
|
|
Success rate of surgery
Tidsramme: 0 to 24 hours after operation
|
The fluid can be infused and withdraw normally, and no pneumothorax, air embolism, mediastinal hematoma surgical complications appeared
|
0 to 24 hours after operation
|
|
the evaluation of the efficiency
Tidsramme: at 1,2,3,4,5,6 month
|
Catheter indwelling time
|
at 1,2,3,4,5,6 month
|
|
the evaluation of the convenience
Tidsramme: intraoperative
|
all the operaters will give a convenience evaluation timely by answering the questionnare
|
intraoperative
|
|
the evaluation of the comfort
Tidsramme: intraoperative
|
physical performance evaluation of the device
|
intraoperative
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Branden-abc
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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