- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: CathiportTM
be used for all kinds of high concentrations of chemotherapeutic drugs, completely parenteral nutrient solution infusion, blood transfusion and blood samples.
|
fully implanted
|
Comparador activo: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Normal usage rate of the equipment
Periodo de tiempo: at 6 months
|
The probability of normally drugs or liquid infusion
|
at 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Success rate of equipment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: at 1,2,3,4,5,6 month
|
Catheter indwelling time
|
at 1,2,3,4,5,6 month
|
the evaluation of the convenience
Periodo de tiempo: intraoperative
|
all the operaters will give a convenience evaluation timely by answering the questionnare
|
intraoperative
|
the evaluation of the comfort
Periodo de tiempo: intraoperative
|
physical performance evaluation of the device
|
intraoperative
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Branden-abc
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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